About

NBCG’s executive committee. From left.: Hans Petter Eikesdal, Egil Støre Blix, Ellen Schlichting, Anne Irene Hagen og Bjørn Naume.

The members of Norwegian Breast Cancer Group are listed with contact information below.

NBCGs executive committee

Professor/senior physician Bjørn Naume, Department for Cancer Treatment, Oslo University Hospital. NBCG leader. bna(a)ous-hf.no
Senior physician Ellen Schlichting, Department for Cancer Treatment, Oslo University Hospital. NBCG deputy. elschl(a)ous-hf.no
Senior physician Hans Petter Eikesdal, Department for Oncology, Haukeland University Hospital, hans.petter.eikesdal(a)helse-bergen.no
Senior physician Anne Irene Hagen, Department for Surgery, St. Olavs Hospital, anne.irene.hagen(a)stolav.no
Senior physician Egil Støre Blix, Department for Cancer Treatment, University Hospital of North Norway, egil.store.blix(a)unn.no

Working Groups

Radiology

  • Solveig Roth Hoff, Ålesund Hospital, leader, sorohoff(a)gmail.com
  • Hildegunn Aase, Haukeland University Hospital, hildegunn.siv.aase(a)helse-bergen.no
  • Linda Romundstad, Vestre Viken Drammen Hospital, linda.romundstad(a)vestreviken.no
  • Gunn Aagedal Hervold, Sørlandet Hospital Kristiansand,  gunn.hervold(a)sshf.no
  • Enno Roedgerts, Nordland Hospital, enno.rodegredts(a)nordlandssykehuset.no

Pathology

  • Lars A. Akslen, Haukeland University Hospital, leader, lars.akslen(a)gades.uib.no
  • Elin Mortensen, Universitety Hospital of North Norway, elin.mortensen(a)unn.no
  • Marianne Brekke,  St Olavs Hospital, marianne.birgitte.brekke(a)stolav.no
  • Jon Lømo, Oslo University Hospital, joloem(a)ous-hf.no
  • Tor Audun Klingen, Vestfold Hospital Tønsberg,  tor.klingen(a)siv.no

Hereditary cancer

  • Hildegunn Høberg Vetti, Haukeland University Hospital, leader, hildegunn.hoberg.vetti(a)helse-bergen.no
  • Solveig Roth Hoff, Ålesund Hospital, sorohoff(a)gmail.com
  • Anne Irene Hagen, St Olavs Hospital, anne.irene.hagen(a)stolav.no
  • Helle Skjerven, Vestre Viken Drammen Hospital, helle.skjerven(a)vestreviken.no
  • Lovise Mæhle, Oslo University Hospital, LOM(a)ous-hf.no
  • Bård Mannsåker, Nordland Hospital, bard.mannsaker(a)nordlandssykehuset.no

Surgery

  • Ellen Schlichting, leader, Oslo University Hospital, elschl(a)ous-hf.no
  • Anne Irene Hagen, St Olavs Hospital, anne.irene.hagen(a)stolav.no
  • Helle Skjerven, Vestre Viken Drammen Hospital, helle.skjerven(a)vestreviken.no
  • Turid Aas/Anette Heie, Haukeland University Hospital, turid.aas(a)helse-bergen.no/ anette.heie(a)helse-bergen.no
  • Marit H. Hansen, Universitety Hospital of North Norway, marit.helene.hansen(a)unn.no

Radiation Therapy

  • Egil Støre Blix, Universitety Hospital of North Norway, leader, egil.store.blix(a)unn.no
  • Ingvil Mjåland, Stavanger Universitety Hospital, mjin(a)sir.no
  • Kristin Reinertsen, Oslo Universitety Hospital, kvr(a)ous-hf.no
  • Bjørn Naume, Oslo Universitety Hospital, bna(a)ous-hf.no

Medical Treatment

  • Hans Petter Eikesdal, Haukeland Universitety Hospital, leader, hans.petter.eikesdal(a)helse-bergen.no
  • Bjørn Naume, Oslo Universitety Hospital, bna(a)ous-hf.no
  • Sunil X Raj, St Olavs Hospital, sunil.xavier.raj(a)stolav.no
  • Olav Engebråten, Oslo Universitety Hospital, oen(a)ous-hf.no


The history of NBCG

Norwegian Breast Cancer Group (NBCG) was founded in its present organization in 1988, but the seed was planted already in 1979. At that time a meeting was held at The Norwegian Radium Hospital dealing with multicenter studies in malignant diseases with a special emphasis on breast cancer. A committee consisting of breast surgeons, pathologists, radiologists and oncologists was established to produce the first national guidelines for the treatment of breast cancer, as well as to initiate and run clinical studies. The guidelines were published in 1981 and were named “The blue book” after the color of the cover. In the years to come, several studies testing both chemotherapy and endocrine treatment in adjuvant and metastatic setting were conducted.

In 1988 the NBCG got its present structure with some minor modifications. Breast surgeons and breast oncologists from university clinics in the four health regions of Norway formed the core of the organization. In addition, surgeons and oncologists from each of the 5 health regions were represented, as well as one (later two) pathologist, one (later two) radiologist and one geneticist. In the later years, a plastic surgeon was also included in NBCG. Today, the steering committee consists of 30 members. The members elect an executive committee consisting of 5 persons, which is responsible for preparing topics to and executing the decisions taken by the steering committee, in addition to “day-to-day” management of NBCG.

NBCG revised the clinical guidelines at regular intervals (1988, 1992, 1994, 1998, 2000, 2003) and worked hard to start multicenter studies in breast cancer treatment within Norway. The steering committee of NBCG meets at a minimum biannually, whereas the executive committee has regular meetings in addition to this. Several working groups  (surgical-, medical oncology-, radiotherapy-, pathology groups) has been established to draft recommendations and facilitate the work and discussion in NBCG concerning treatment, diagnostics, and research. NBCG has over the last 16 – 17 years adjusted and revised the NBCG guidelines for treating breast cancer every 6 months. This work has ensured a uniform approach to treatment of the individual patient all over Norway. NBCG was instrumental in writing the first National guidelines for breast cancer published by The Norwegian Directorate of Health and is performing revisions one or two times a year. NBCG was also instrumental in writing “The Breast cancer patient care pathway” (“Pakkeforløp for brystkreft”) securing patients the right to be diagnosed and treated within a certain timeframe. The organizational structure of NBCG has in the years after 1988 been blueprinted by most of the tumor groups in Norway (GI-cancer, lung cancer etc.). NBCG has also had a key role in establishing a National Breast Cancer Quality Registry, both as an initiator, planner and creator, – in close collaboration with the Cancer Registry of Norway. This Registry can now be used both to monitor the quality of diagnosis and treatment of breast cancer in Norway, to run decision impact studies and to provide clinicopathological data to clinical and translational studies.

During the years, the group has focused on breast cancer research in several ways. Studies have been initiated where NBCG was the key initiator and executive board for the studies. During the years, more commonly key clinical scientists (many being members of the NBCG) has presented ideas or protocol drafts for studies to NBCG, followed by a collaborative discussion, initiation and execution of the studies. The involvement from NBCG in most of these studies has been instrumental to achieve participation from hospitals all over the country securing both recruitment and study availability for the patients. In the later years, NBCG has also focused on facilitating inclusion in other breast cancer studies in Norway, although outside NBCGs responsibility (including several industry-sponsored trials). An overview (with inclusion/exclusion criteria) of all ongoing studies in Norway (with regular updates) has been established on NBCG’s website, also including an overview based on the clinical situation for the individual patient (see nbcg.no). All new proposed clinical studies (either investigator-initiated or industry-sponsored, irrespective of being suitable as an NBCG study, are presented at the steering committee meeting. Therefore, NBCG has a key role to inform about, discuss, facilitate initiation of and support Norwegian studies of breast cancer in general, as well as being an active part in conducting NBCG studies. In addition, NBCG collaborate with the Scandinavian breast group, Breast International Group (NBCG is a member) as well as other profiled international study groups, in conducting international multicenter trials. Important international multicenter studies could also be strongly supported by NBCG but staying outside the “NBCG umbrella”. These studies are not presented in the following.  The list of publications with a significant contribution from NBCG, is presented below. Many of the studies have also produced additional manuscripts not referred in the list. However, as there are translational sub-studies, spin-off sub-studies or updates where the contribution by NBCG as a group is minimal, these have been omitted.

Brief overview of the core study activities:

The first trials (Studies before NBCG-numbering was started) tested chemotherapy and endocrine treatment in metastatic breast cancer. Thereafter, the first NBCG-numbered trials (NBCG 1 – 3) studied the effect of various adjuvant endocrine treatments of breast cancer. Furthermore, NBCG has tested the clinical benefit of adjuvant treatment with aromatase inhibitor (NBCG/Exe 027), the side effects of aromatase inhibitors versus placebo (NBCG/Exe 031). NBCG also participated in the multicenter trial testing estrogen substitution after breast cancer (NBCG/HABITS). The NBCG5 study tested bisfosfonate (clodronate) as part of adjuvant treatment. Several studies of chemotherapy both in the adjuvant and metastatic setting have been conducted through the years. In collaboration with the Scandinavian Breast Group, high dose chemotherapy and autologous stem cell support was tested against dose-escalated FEC chemotherapy as adjuvant treatment in high-risk breast cancer patients (NBCG/SBG9401). In a different study, docetaxel was tested against methotrexate/5FU in anthracycline-resistant metastatic breast cancer (NBCG/SBG9404). In Norway, weekly paclitaxel versus docetaxel three-weekly was studied in advanced breast cancer (NBCG10). As a part of large international studies, NBCG has participated in several trials testing HER2-directed (targeted) adjuvant treatment added to chemotherapy (trastuzumab vs control; trastuzumab vs lapatinib vs trastuzumab/lapatinib)(NBCG/HERA; NBCG12/ALTTO; NBCG13/NeoALTTO). NBCG has had a significant focus on participating in and/or support studies of neoadjuvant treatment, in order to perform in-depth molecular studies of the effect of various systemic treatments on the primary tumor, aiming at identifying tumor signatures/factors associated with resistance or sensitivity to antracyclins, taxans, cyclophosphamide, carboplatin, targeted treatments (HER2-directed, PARP-inhibition, anti-angiogenic treatments)(NBCG6/NeoTAX: recruitment completed, analyses ongoing; NeoAVA: recruitment completed, analyses ongoing; PETREMAC: ongoing; I-BCT: ongoing). Extending the studies of (neo)adjuvant treatment, NBCG has also been importantly involved in conducting a study to test the effect of secondary adjuvant treatment of patients with presence of single disseminated tumor cells in the bone marrow 8-9 months after anthracycline-containing chemotherapy (NBCG9/SATT: recruitment completed, analyses ongoing). Concerning radiotherapy, a study of hypo-fractionated locoregional treatment and integrated boost in breast cancer is conducted by some of the NBCG investigators in collaboration with an international radiotherapy group (SKAGEN1: ongoing). In collaboration with IBCSG, NBCG participates in the POSITIVE trial, testing abruption of endocrine adjuvant treatment to allow pregnancy (NBCG16/IBCSG 48-14: ongoing). Studies of check-point blockade in advanced breast cancer is the focus of two recently launched Norwegian studies, testing immunogenic chemotherapy (liposomal doxorubicin 2qw + oral cyclophosphamide 2/4 weeks) +/- azetolizumab (anti-PD-L1) in triple negative breast cancer (NBCG17/ALICE) and immunogenic chemotherapy +/- nivolumab (anti-PD1) and low dose ipililumab (anti-CTLA4)(NBCG18/ICON). Aiming at primarily reducing overtreatment with adjuvant chemotherapy and establishing molecular breast cancer profiling within all Norwegian health regions, two large NBCG studies will open fall 2018, using Prosigna test for classification of patients into refined prognostic groups, – with participation from 15 hospitals in Norway (NBCG19/EMIT1 for node negative; NBCG20/OPTIMA for node positive in collaboration with the UK OPTIMA study group). In addition, a new NBCG supported neoadjuvant study is planned to be launched early 2019 (PETREMAC2). A list of the studies is provided below.

In conclusion, NBCG has through both its work with national clinical guidelines and its fight for the patients’ right to be treated according to these guidelines, as well as the focus on research and conducting clinical trials, established itself as a beacon in the field of breast cancer in Norway.

Overview of NBCG studies (not included studies supported by NBCG but without NBCG involvement)

Study NBCG-numbering   Reference/
comment
1 Svenocam1 Weekly Adriamycin versus VAC in dvanced breast cancer. A randomized trial. 1
2 Svenocam2 Weekly Adriamycin vs. 4-epidoxorubicin every second week in dvanced breast cancer. A randomized trial. 2
3 Svenocam3 Megestrol acetate versus aminoglutethimide for metastatic breast cancer. 3
4 NBCG1 Adjuvant tamoxifen for pre- and postmenopausal women with estrogen receptor positive, node positive breast cancer: a randomized study. 4, 8
5 NBCG2 Adjuvant endocrine treatment (goserelin vs tamoxifen) in pre-menopausal patients with operable node positive stage II breast cancer. A prospective randomized national multicenter study. 5, 8
6 NBCG3 Cyclical use of tamoxifen and high-dose medroxyprogesterone acetate in advanced estrogen receptor positive breast cancer. 6-8
7   Droloxifen study 1: Influence of treatment with the anti-oestrogen 3-hydroxytamoxifen (droloxifene) on plasma sex hormone levels in postmenopausal patients with breast cancer 36
8  – Droloxifen study 2: Influence  of droloxifene on metastatic breast cancer as first-line endocrine treatment. 37
9 NBCG4 Protocol for treatment and FU of in situ carcinomas Premature closure
 (no results)
10 SBG9401 Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer: a randomised trial. 27-29
11  SBG9404 Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure 30
12 NBCG5 Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer. 9
13 Exe027 A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. 32-35
14 NBCG6/
NeoTax
Evaluation of epi-adriamycin versus paclitaxel for primary medical treatment (“neo-adjuvant chemotherapy” in patients with locally advanced (stage III, T3/4 and/or N2) non-inflammatory breast cancer with or without limited distant metastases; phase II study 10-14, analyses ongoing
15 NBCG7/
Exe031
Effects of exemestane administered for 2 years versus placebo on bone mineral density, bone biomarkers, and plasma lipids in patients with surgically resected early breast cancer. 15-16
16 HERA Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. 26
  HABITS Hormone replacement therapy in breast cancer survivors – is it safe. 31
17 NBCG8 Evaluation of clinical effects of and predictive factors to docetaxel and trastuzumab in sequence followed by combination as first line treatment in patients with HER2-positive breast cancers. Closed before study was  started
18 NBCG9/
SATT
Secondary Adjuvant (rescue) Treatment with docetaxel (Taxotere) and detection of isolated tumor cells in bone marrow as a surrogate marker for effect – in node positive and high risk node negative breast cancer after standard adjuvant epirubicin-containing treatment (SATT) 17-19, analyses ongoing
19 NBCG10 Weekly Paclitaxel plus Capecitabine versus Docetaxel Every 3 Weeks plus Capecitabine in Metastatic Breast Cancer. 20
20 NBCG11/
ABCSG21
A randomized phase II study comparing anastrozole and fulvestrant to anastrozole for adjuvant treatment of postmenopausal patients with early breast cancer and disseminated tumour cells in bone marrow Premature closure
(no results)
21 NBCG12/
ALTTO
Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation study. A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their  combination in patients 21,22
22 NBCG13/
NeoALTTO
NeoALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study. A randomised, multicentre, open-label, phase III study of neoadjuvant lapatinib, trastuzumab, and their combination plus paclitaxel in women with HER2/ErbB2 positive primary breast cancer 23,24
23 NBCG14/
EBBA2
Energy Balance and Breast Cancer Aspects (EBBA2) 25
Closed for inclusion, follow up and analyses ongoing
24 NBCG15/
PETREMAC
PErsonalized TREatment of high-risk MAmmary Cancer – the PETREMAC Trial Ongoing recruitment
25 NBCG16/
IBCSG 48-14
Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer Ongoing recruitment
26 NBCG17/
ALICE
Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer Ongoing recruitment
27 NBCG18/
ICON
A randomized phase IIb study evaluating immunogenic chemotherapy combined with ipilimumab and nivolumab in patients with luminal B breast cancer. Ongoing recruitment
28 NBCG19/
EMIT1
Establishment of Molecular profiling for Individual clinical routine Treatment decision in Early Breast Cancer Ongoing recruitment
29 NBCG20/
OPTIMA
Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis (OPTIMA)/ EMITEBC-2 Ongoing recruitment
30 NBCG21/
NATURAL (DBCG)
Partial Breast Versus no Irradiation for Women >=60 Years Operated With Breast Conservation for Early Breast Cancer: a Clinically Controlled Randomized Phase III Trial Ongoing recruitment

Studies being planned

1
PETREMAC2
PErsonalized TREatment of high-risk MAmmary Cancer – the PETREMAC 2 Trial  
2 INDAX Individualized axillary treatment of initially biopsy-proven node-positive breast cancer after neoadjuvant chemotherapy: the EUBREAST-2 INDAX Trial  

Reference list for NBCG studies (mainly investigator-initiated)(according to study)

Pre NBCG numbered studies (SVENOCAM)

1. Gundersen S, Kvinnsland S, Klepp O, Kvaløy S, Lund E, Høst H. Weekly adriamycin versus VAC in advanced breast cancer. A randomized trial. Eur J Cancer Clin Oncol. 1986 Dec;22(12):1431-4. PubMed PMID: 3595668.

2. Lundgren S, Gundersen S, Klepp R, Lønning PE, Lund E, Kvinnsland S. Megestrol acetate versus aminoglutethimide for metastatic breast cancer. Breast Cancer Res Treat. 1989 Nov;14(2):201-6. PubMed PMID: 2690972.

3. Gundersen S, Kvinnsland S, Klepp O, Lund E, Høst H. Weekly Adriamycin vs. 4-epidoxorubicin every second week in advanced breast cancer. A randomized trial. The Norwegian Breast Cancer Group. Eur J Cancer. 1990 Jan;26(1):45-8. PubMed PMID: 2138477.

NBCG1

4. Gundersen S, Hannisdal E, Søreide JA, Skarstein A, Varhaug JE. Adjuvant tamoxifen for pre- and postmenopausal women with estrogen receptor positive, node positive breast cancer: a randomized study. Breast Cancer Res Treat. 1995;36(1):49-53. PubMed PMID: 7579506.

NBCG2

5. Söreide JA, Varhaug JE, Fjösne HE, Erikstein B, Jacobsen AB, Skovlund E, Kvinnsland S. Adjuvant endocrine treatment (goserelin vs tamoxifen) in pre-menopausal patients with operable node positive stage II breast cancer. A prospective randomized national multicenter study. Eur J Surg Oncol. 2002 Aug;28(5):505-10. PubMed PMID: 12217302.

NBCG3

6. Gundersen S, Kvinnsland S, Lundgren S, Klepp O, Lund E, Børmer O, Høst H. Cyclical use of tamoxifen and high-dose medroxyprogesterone acetate in advanced estrogen receptor positive breast cancer. Breast Cancer Res Treat. 1990 Nov;17(1):45-50. PubMed PMID: 2151369.

7. Fjøsne HE, Jacobsen AB, Lundgren S; Norwegian Breast Cancer Group (NBCG). Adjuvant cyclic Tamoxifen and Megestrol acetate treatment in postmenopausal breast cancer patients–longterm follow-up. Eur J Surg Oncol. 2008 Jan;34(1):6-12. Epub 2007 Sep 18. PubMed PMID: 17881183.

NBCG 1-3 (pooled study)

8. Fjösne HE, Søreide JA, Kåresen R, Lønning PE, Jacobsen AB, Lundgren S; NORWEGIAN BREAST CANCER GROUP (NBCG). Hospital volume and prognosis among Norwegian breast cancer patients enrolled in adjuvant trials. Acta Oncol. 2011 Oct;50(7):1068-74. doi: 0.3109/0284186X.2011.585998. Epub 2011 Jul 11. PubMed PMID: 21745131.

NBCG4 (DCIS protocol) (Premature closure; no results)

NBCG5 (bisphosphonate adjuvant)

9. Powles T, Paterson S, Kanis JA, McCloskey E, Ashley S, Tidy A, Rosenqvist K, Smith I, Ottestad L, Legault S, Pajunen M, Nevantaus A, Männistö E, Suovuori A, Atula S, Nevalainen J, Pylkkänen L. Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer. J Clin Oncol. 2002 Aug 1;20(15):3219-24. PubMed PMID: 12149294.

NBCG6

10. Knappskog S, Berge EO, Chrisanthar R, Geisler S, Staalesen V, Leirvaag B, Yndestad S, de Faveri E, Karlsen BO, Wedge DC, Akslen LA, Lilleng PK, Løkkevik E, Lundgren S, Østenstad B, Risberg T, Mjaaland I, Aas T, Lønning PE. Concomitant inactivation of the p53- and pRB- functional pathways predicts resistance to DNA  damaging drugs in breast cancer in vivo. Mol Oncol. 2015 Oct;9(8):1553-64. doi: 10.1016/j.molonc.2015.04.008. Epub 2015 May 8. PubMed PMID: 26004085; PubMed Central PMCID: PMC5528784.

11. Knappskog S, Gansmo LB, Romundstad P, Bjørnslett M, Trovik J, Sommerfelt-Pettersen J, Løkkevik E; Norwegian Breast Cancer Group trial NBCG VI,  Tollenaar RA, Seynaeve C, Devilee P, Salvesen HB, Dørum A, Hveem K, Vatten L, Lønning PE. MDM2 promoter SNP344T>A (rs1196333) status does not affect cancer risk. PLoS One. 2012;7(4):e36263. doi: 10.1371/journal.pone.0036263. Epub 2012 Apr 30. PubMed PMID: 22558411; PubMed Central PMCID: PMC3340411.

12. Chrisanthar R, Knappskog S, Løkkevik E, Anker G, Østenstad B, Lundgren S, Berge EO, Risberg T, Mjaaland I, Maehle L, Engebretsen LF, Lillehaug JR, Lønning  PE. CHEK2 mutations affecting kinase activity together with mutations in TP53 indicate a functional pathway associated with resistance to epirubicin in primary breast cancer. PLoS One. 2008 Aug 26;3(8):e3062. doi: 10.1371/journal.pone.0003062. PubMed PMID: 18725978; PubMed Central PMCID: PMC2518116.

13. Chrisanthar R, Knappskog S, Løkkevik E, Anker G, Ostenstad B, Lundgren S, Risberg T, Mjaaland I, Skjønsberg G, Aas T, Schlichting E, Fjösne HE, Nysted A, Lillehaug JR, Lønning PE. Predictive and prognostic impact of TP53 mutations and  MDM2 promoter genotype in primary breast cancer patients treated with epirubicin or paclitaxel. PLoS One. 2011 Apr 27;6(4):e19249. doi: 10.1371/journal.pone.0019249. PubMed PMID: 21556366; PubMed Central PMCID: PMC3083424.

14. Mathiesen RR, Borgen E, Renolen A, Løkkevik E, Nesland JM, Anker G, Ostenstad  B, Lundgren S, Risberg T, Mjaaland I, Kvalheim G, Lønning PE, Naume B. Persistence of disseminated tumor cells after neoadjuvant treatment for locally advanced breast cancer predicts poor survival. Breast Cancer Res. 2012 Aug 14;14(4):R117. doi: 10.1186/bcr3242. PubMed PMID: 22889108; PubMed Central PMCID: PMC3680942.

NBCG7

15. Lønning PE, Geisler J, Krag LE, Erikstein B, Bremnes Y, Hagen AI, Schlichting  E, Lien EA, Ofjord ES, Paolini J, Polli A, Massimini G. Effects of exemestane administered for 2 years versus placebo on bone mineral density, bone biomarkers, and plasma lipids in patients with surgically resected early breast cancer. J Clin Oncol. 2005 Aug 1;23(22):5126-37. Epub 2005 Jun 27. PubMed PMID: 15983390.

16. Geisler J, Lønning PE, Krag LE, Løkkevik E, Risberg T, Hagen AI, Schlichting E, Lien EA, Ofjord ES, Eide GE, Polli A, di Salle E, Paolini J. Changes in bone and lipid metabolism in postmenopausal women with early breast cancer after terminating 2-year treatment with exemestane: a randomised, placebo-controlled study. Eur J Cancer. 2006 Nov;42(17):2968-75. Epub 2006 Sep 11. PubMed PMID: 16963261.

NBCG8 (closed before the study was started)

NBCG9

17. Synnestvedt M, Borgen E, Wist E, Wiedswang G, Weyde K, Risberg T, Kersten C,  Mjaaland I, Vindi L, Schirmer C, Nesland JM, Naume B. Disseminated tumor cells as selection marker and monitoring tool for secondary adjuvant treatment in early breast cancer. Descriptive results from an intervention study. BMC Cancer. 2012 Dec 22;12:616. doi: 10.1186/1471-2407-12-616. PubMed PMID: 23259667; PubMed Central PMCID: PMC3576235.

18. Gilje B, Nordgård O, Tjensvoll K, Borgen E, Synnestvedt M, Smaaland R, Naume B. Comparison of molecular and immunocytochemical methods for detection of disseminated tumor cells in bone marrow from early breast cancer patients. BMC Cancer. 2014 Jul 15;14:514. doi: 10.1186/1471-2407-14-514. PubMed PMID: 25023626; PubMed Central PMCID: PMC4223548.

19. Naume B, Synnestvedt M, Falk RS, Wiedswang G, Weyde K, Risberg T, Kersten C,  Mjaaland I, Vindi L, Sommer HH, Sætersdal AB, Rypdal MC, Bendigtsen Schirmer C, Wist EA, Borgen E. Clinical outcome with correlation to disseminated tumor cell (DTC) status after DTC-guided secondary adjuvant treatment with docetaxel in early breast cancer. J Clin Oncol. 2014 Dec 1;32(34):3848-57. doi: 10.1200/JCO.2014.56.9327. Epub 2014 Nov 3. PubMed PMID: 25366688.

NBCG10

 20. Wist EA, Mjaaland I, Løkkevik E, Sommer HH. Weekly Paclitaxel plus Capecitabine versus Docetaxel Every 3 Weeks plus Capecitabine in Metastatic Breast Cancer. J Oncol. 2012;2012:862921. doi: 10.1155/2012/862921. Epub 2012 Jan 15. PubMed PMID: 22291703; PubMed Central PMCID: PMC3265117.

NBCG11 (ABCSG21) (Premature closure; no results)

NBCG12

21. Piccart-Gebhart M, Holmes E, Baselga J, de Azambuja E, Dueck AC, Viale G, Zujewski JA, Goldhirsch A, Armour A, Pritchard KI, McCullough AE, Dolci S, McFadden E, Holmes AP, Tonghua L, Eidtmann H, Dinh P, Di Cosimo S, Harbeck N, Tjulandin S, Im YH, Huang CS, Diéras V, Hillman DW, Wolff AC, Jackisch C, Lang I, Untch M, Smith I, Boyle F, Xu B, Gomez H, Suter T, Gelber RD, Perez EA. Adjuvant Lapatinib and Trastuzumab for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Results From the Randomized Phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Trial. J Clin Oncol. 2016 Apr 1;34(10):1034-42. doi: 10.1200/JCO.2015.62.1797. Epub 2015 Nov 23. PubMed PMID: 26598744; PubMed Central PMCID: PMC4872016.

22. Gingras I, Holmes E, De Azambuja E, Nguyen DH, Izquierdo M, Anne Zujewski J,  Inbar M, Naume B, Tomasello G, Gralow JR, Wolff AC, Harris L, Gnant M, Moreno-Aspitia A, Piccart MJ, Azim HA Jr. Regional Nodal Irradiation After Breast Conserving Surgery for Early HER2-Positive Breast Cancer: Results of a Subanalysis From the ALTTO Trial. J Natl Cancer Inst. 2017 Aug 1;109(8). doi: 10.1093/jnci/djw331. PubMed PMID: 28376188.

NBCG13

23. Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gómez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horváth Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012 Feb 18;379(9816):633-40. doi: 10.1016/S0140-6736(11)61847-3. Epub 2012 Jan 17. Erratum in: Lancet. 2012 Feb 18;379(9816):616. Dosage error in published abstract; MEDLINE/PubMed abstract corrected. PubMed PMID: 22257673; PubMed Central PMCID: PMC5705192.

24. Di Cosimo S, Campbell C, Azim HA Jr, Galli G, Bregni G, Curigliano G, Criscitiello C, Izquierdo M, de la Pena L, Fumagalli D, Fein L, Vinholes J, Ng WMJ, Colleoni M, Ferro A, Naume BJ, Patel A, Huober J, Piccart-Gebhart MJ, Baselga J, de Azambuja E. The use of breast imaging for predicting response to neoadjuvant lapatinib, trastuzumab and their combination in HER2-positive breast cancer: Results from Neo-ALTTO. Eur J Cancer. 2018 Jan;89:42-48. doi: 10.1016/j.ejca.2017.10.036. Epub 2017 Dec 8. PubMed PMID: 29227816; PubMed Central PMCID: PMC5777154.

NBCG14/EBBA2

25. Vaysse C, Lømo J, Garred Ø, Fjeldheim F, Lofteroed T, Schlichting E, McTiernan A, Frydenberg H, Husøy A, Lundgren S, Fagerland MW, Richardsen E, Wist  EA, Muller C, Thune I. Erratum: Inflammation of mammary adipose tissue occurs in  overweight and obese patients exhibiting early-stage breast cancer. NPJ Breast Cancer. 2017 Sep 5;3:35. doi: 10.1038/s41523-017-0030-x. eCollection 2017. PubMed PMID: 28884144; PubMed Central PMCID: PMC5585409.  (Phila). 2015 Jun;8(6):535-44. doi: 10.1158/1940-6207.CAPR-14-0267. Epub 2015 Mar 24.

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26. Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Sánchez Rovira P, Piccart-Gebhart MJ; HERA study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007 Jan 6;369(9555):29-36. PubMed PMID: 17208639.

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 27. Brandberg Y, Michelson H, Nilsson B, Bolund C, Erikstein B, Hietanen P, Kaasa S, Nilsson J, Wiklund T, Wilking N, Bergh J; Scandinavian Breast Group Study 9401. Quality of life in women with breast cancer during the first year after random assignment to adjuvant treatment with marrow-supported high-dose chemotherapy with cyclophosphamide, thiotepa, and carboplatin or tailored therapy with Fluorouracil, epirubicin, and cyclophosphamide: Scandinavian Breast Group Study 9401. J Clin Oncol. 2003 Oct 1;21(19):3659-64. PubMed PMID: 14512398.

28. Bergh J, Wiklund T, Erikstein B, Lidbrink E, Lindman H, Malmström P, Kellokumpu-Lehtinen P, Bengtsson NO, Söderlund G, Anker G, Wist E, Ottosson S, Salminen E, Ljungman P, Holte H, Nilsson J, Blomqvist C, Wilking N. Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer: a randomised trial. Scandinavian Breast Group 9401 study. Lancet. 2000 Oct 21;356(9239):1384-91.

29. Drageset V, Nesland JM, Erikstein B, Skovlund E, Sommer H, Anker G, Wist E, Lundgren S, Bergh J, Kvalheim G. Monitoring of disseminated tumor cells in bone marrow in high-risk breast cancer patients treated with high-dose chemotherapy. Int J Cancer. 2006 Jun 1;118(11):2877-81. PubMed PMID: 16381016

SBG9404

30. Sjöström J, Blomqvist C, Mouridsen H, Pluzanska A, Ottosson-Lönn S, Bengtsson  NO, Ostenstad B, Mjaaland I, Palm-Sjövall M, Wist E, Valvere V, Anderson H, Bergh J. Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandinavian Breast Group. Eur J Cancer. 1999 Aug;35(8):1194-201. PubMed PMID: 10615229.

HABITS

31. Holmberg L(1), Iversen OE, Rudenstam CM, Hammar M, Kumpulainen E, Jaskiewicz J, Jassem J, Dobaczewska D, Fjosne HE, Peralta O, Arriagada R, Holmqvist M, Maenpaa  J; HABITS Study Group. Increased risk of recurrence after hormone replacement therapy in breast cancer survivors. J Natl Cancer Inst. 2008 Apr 2;100(7):475-82. doi: 10.1093/jnci/djn058. Epub 2008 Mar 25.

Exemestane adjuvant 027

 32.Morden JP, Alvarez I, Bertelli G, Coates AS, Coleman R, Fallowfield L, Jassem  J, Jones S, Kilburn L, Lønning PE, Ortmann O, Snowdon C, van de Velde C, Andersen J, Del Mastro L, Dodwell D, Holmberg S, Nicholas H, Paridaens R, Bliss JM, Coombes RC. Long-Term Follow-Up of the Intergroup Exemestane Study. J Clin Oncol. 2017 Aug 1;35(22):2507-2514. doi: 10.1200/JCO.2016.70.5640. Epub 2017 May 3. PubMed PMID: 28467729.

 33. Bliss JM, Kilburn LS, Coleman RE, Forbes JF, Coates AS, Jones SE, Jassem J, Delozier T, Andersen J, Paridaens R, van de Velde CJ, Lønning PE, Morden J, Reise J, Cisar L, Menschik T, Coombes RC. Disease-related outcomes with long-term follow-up: an updated analysis of the intergroup exemestane study. J Clin Oncol.  2012 Mar 1;30(7):709-17. doi: 10.1200/JCO.2010.33.7899. Epub 2011 Oct 31. PubMed  PMID: 22042946.

34. Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, Jones SE, Alvarez I, Bertelli G, Ortmann O, Coates AS, Bajetta E, Dodwell D, Coleman RE, Fallowfield LJ, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Stewart A, Stuart N, Snowdon CF, Carpentieri M, Massimini G, Bliss JM, van de Velde C; Intergroup Exemestane Study. A randomized trial of exemestane after two to three  years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004 Mar 11;350(11):1081-92. Erratum in: N Engl J Med. 2004 Dec 2;351(23):2461. N Engl J Med. 2006 Oct 19;355(16):1746. van de Velde, Cornelius. PubMed PMID: 15014181.

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Droloxifen study 1

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Droloxifen study 2

37. Haarstad H, Lønning PE, Gundersen S, Wist E, Raabe N, Kvinnsland S. Influence  of droloxifene on metastatic breast cancer as first-line endocrine treatment. Acta Oncol. 1998;37(4):365-8. PubMed PMID: 9743458.

Other relevant studies

38. Francolini G, Thomsen MS, Yates ES, Kirkove C, Jensen I, Blix ES, Kamby C, Nielsen MH, Krause M, Berg M, Mjaaland I, Schreiber A, Kasti UM, Boye K, Offersen BV. Quality assessment of delineation and dose planning of early breast cancer patients included in the randomized Skagen Trial 1. Radiother Oncol. 2017 May;123(2):282-287. doi: 10.1016/j.radonc.2017.03.011. Epub 2017 Mar 25. PubMed PMID: 28351523.

39. Dumeaux V, Fjukstad B, Fjosne HE, Frantzen JO, Holmen MM, Rodegerdts E, Schlichting E, Børresen-Dale AL, Bongo LA, Lund E, Hallett M. Interactions between the tumor and the blood systemic response of breast cancer patients. PLoS Comput Biol. 2017 Sep 28;13(9):e1005680. doi: 10.1371/journal.pcbi.1005680. eCollection 2017 Sep. PubMed PMID: 28957325; PubMed Central PMCID: PMC5619688.

40. Dumeaux V, Ursini-Siegel J, Flatberg A, Fjosne HE, Frantzen JO, Holmen MM, Rodegerdts E, Schlichting E, Lund E. Peripheral blood cells inform on the presence of breast cancer: a population-based case-control study. Int J Cancer. 2015 Feb 1;136(3):656-67. doi: 10.1002/ijc.29030. Epub 2014 Jun 25. PubMed PMID: 24931809; PubMed Central PMCID: PMC4278533.

41. Norum J, Olsen JA, Wist EA, Lønning PE. Trastuzumab in adjuvant breast cancer  therapy. A model based cost-effectiveness analysis. Acta Oncol. 2007;46(2):153-64. PubMed PMID: 17453363. 0

 42. Eldesoky AR, Yates ES, Nyeng TB, Thomsen MS, Nielsen HM, Poortmans P, Kirkove C, Krause M, Kamby C, Mjaaland I, Blix ES, Jensen I, Berg M, Lorenzen EL, Taheri-Kadkhoda Z, Offersen BV. Internal and external validation of an ESTRO delineation guideline – dependent automated segmentation tool for loco-regional radiation therapy of early breast cancer. Radiother Oncol. 2016 Dec;121(3):424-430. doi: 10.1016/j.radonc.2016.09.005. PubMed PMID: 27697296.