- Solveig Roth Hoff, Ålesund sykehus, leder, sorohoff(a)gmail.com
- Hildegunn Aase, Haukeland universitetssykehus, hildegunn.siv.aase(a)helse-bergen.no
- Linda Romundstad, Vestre Viken Drammen sykehus, linda.romundstad(a)vestreviken.no
- Gunn Aagedal Hervold, Sørlandet Sykehus Kristiansand, gunn.hervold(a)sshf.no
- Enno Roedgerts, Nordlandssykehuset, enno.rodegredts(a)nordlandssykehuset.no
- Lars A. Akslen, Haukeland universitetssykehus, leder, lars.akslen(a)gades.uib.no
- Elin Mortensen, Universitetssykehuset Nord-Norge, elin.mortensen(a)unn.no
- Marianne Brekke, St Olavs hospital, marianne.birgitte.brekke(a)stolav.no
- Jon Lømo, Oslo universitetssykehus, joloem(a)ous-hf.no
- Tor Audun Klingen, Sykehuset i Vestfold Tønsberg, tor.klingen(a)siv.no
- Hildegunn Høberg Vetti, Haukeland universitetssykehus, leder, hildegunn.hoberg.vetti(a)helse-bergen.no
- Solveig Roth Hoff, Ålesund sykehus, sorohoff(a)gmail.com
- Anne Irene Hagen, St Olavs hospital, anne.irene.hagen(a)stolav.no
- Helle Skjerven, Vestre Viken Drammen sykehus, helle.skjerven(a)vestreviken.no
- Lovise Mæhle, Oslo universitetssykehus, LOM(a)ous-hf.no
- Bård Mannsåker, Nordlandssykehuset, bard.mannsaker(a)nordlandssykehuset.no
- Ellen Schlichting, leder, Oslo universitetssykehus, elschl(a)ous-hf.no
- Anne Irene Hagen, St Olavs hospital, anne.irene.hagen(a)stolav.no
- Helle Skjerven, Vestre Viken Drammen sykehus, helle.skjerven(a)vestreviken.no
- Turid Aas/Anette Heie, Haukeland universitetssykehus, turid.aas(a)helse-bergen.no/ anette.heie(a)helse-bergen.no
- Marit H. Hansen, Universitetssykehuset Nord-Norge, marit.helene.hansen(a)unn.no
- Egil Støre Blix, Universitetssykehuset Nord-Norge, leder, egil.store.blix(a)unn.no
- Ingvil Mjåland, Stavanger universitetssykehus, mjin(a)sir.no
- Kristin Reinertsen, Oslo universitetssykehus, kvr(a)ous-hf.no
- Bjørn Naume, Oslo universitetssykehus, bna(a)ous-hf.no
- Hans Petter Eikesdal, Haukeland universitetssykehus, leder, hans.petter.eikesdal(a)helse-bergen.no
- Bjørn Naume, Oslo universitetssykehus, bna(a)ous-hf.no
- Sunil X Raj, St Olavs hospital, sunil.xavier.raj(a)stolav.no
- Olav Engebråten, Oslo universitetssykehus, oen(a)ous-hf.no
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
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)
|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||
|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|
|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|
|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|
|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|
|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|
|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|
|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|
|Energy Balance and Breast Cancer Aspects (EBBA2)||
Closed for inclusion, follow up and analyses ongoing
|PErsonalized TREatment of high-risk MAmmary Cancer – the PETREMAC Trial||Ongoing recruitment|
|Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer||Ongoing recruitment|
|Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer||Ongoing recruitment|
|A randomized phase IIb study evaluating immunogenic chemotherapy combined with ipilimumab and nivolumab in patients with luminal B breast cancer.||Ongoing recruitment|
|Establishment of Molecular profiling for Individual clinical routine Treatment decision in Early Breast Cancer||Ongoing recruitment|
|Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis (OPTIMA)/ EMITEBC-2||Ongoing recruitment|
|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
|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.
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.
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.
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.
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.
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)
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.
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)
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.
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.
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.
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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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.
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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.