Country

The Netherlands

President

Professor Dr J.G.M. Klijn, Erasmus MC/DDHK, P.O. Box 5201, 3008 AE ROTTERDAM, THE NETHERLANDS, Tel: +31 10 439 17 33 Fax: +31 10 439 10 03 Email: [email protected]

Treasurer and Vice-President

Professor Dr J.W.R. Nortier Leiden University Medical Center, Department of Clinical Oncology, P.O. Box 9600, 2300 RC LEIDEN, THE NETHERLANDS, Tel: +31 71 526 30 57 Fax: +31 71 526 67 60, Email: [email protected]

Secretary

Dr A.H. Westenberg, Arnhems RTI, Wagnerlaan 47, 6815 AD ARNHEM, THE NETHERLANDS, Tel: +31 26 371 24 93 Fax: +31 26 443 12 00, Email: [email protected]

Dr E.J.Th. Rutgers, Netherlands Cancer Institute-AvL, Plesmanlaan 121, 1066 CX AMSTERDAM, THE NETHERLANDS Tel: +31 20 512 2 551 Fax: +31 20 512 25 54, Email: [email protected]

Dr M.J. van de Vijver, Netherlands Cancer Institute-AvL, Plesmanlaan 121, 1066 CX AMSTERDAM, THE NETHERLANDS, Tel: +31 20 512 27 51 Fax: +31 20 512 27 59, Email: [email protected]

Research Manager

Dr A.E. van Leeuwen-Stok, P.O. Box 9236, 1006 AE AMSTERDAM, THE NETHERLANDS, Tel: +31 20 346 25 47 Fax: +31 20 346 25 25 Email: [email protected]

Office

BOOG, P.O. Box 9236, 1006 AE AMSTERDAM, THE NETHERLANDS, Tel: +31 20 346 25 47/44 Fax: 31 20 346 25 25, Email: [email protected]

Website

http://BOOG.ikcnet.nl

Title

An open label randomized (inter)national multicenter comparative trial of 5 years adjuvant endocrine therapy with an LHRH agonist plus an aromatase inhibitor (goserelin + anastrozole) versus five courses FE90C chemotherapy followed by the same endocrine therapy in pre- or perimenopausal patients with hormone receptor-positive primary breast cancer (PRemenopausal Optimal Management IS Endocrine therapy).

BOOG 2002-01/PROMISE

ISRCTN23561723

Coordinator(s)

J.G.M. Klijn, Erasmus MC/DDHK, P.O. Box 5201, 3008 AE ROTTERDAM, THE NETHERLANDS, Tel: +31 10 4391733 Fax: +31 10 4391003, Email: [email protected]

Summary

Primary Objective

• Relapse-free survival (RFS): Compare immediate optimal endocrine adjuvant therapy (goserelin + anastrozole) with standard chemotherapy followed by the same optimal endocrine treatment in terms of time to recurrence of breast cancer (defined as the earliest local recurrence, new primary breast cancer, or death).

Secondary Objectives

• overall survival (os), the incidence of contralateral breast cancer;
• safety and long-term tolerability of both treatment regimens.

Scheme

Update

• Target accrual: Approximately 2300 patients.
• Start date: 1 July 2005.
• 1st amendment November 2005, 2nd amendment March 2006.
• Exclusion Her2+ patients, N+ : six courses TAC instead of five courses FE90C chemotherapy, longer accrual period.

Related Publications

None available

Topics

• Hormonal therapy
• Pre-/perimenopausal patients
• Hormone receptor positive breast cancer
• HER2 negative patients

Keywords

None available

***************************************************

Title

Open label, comparative, randomized, multicenter, study of trastuzumab (Herceptin) given with docetaxel (Taxotere) versus sequential single agent therapy with trastuzumab followed by docetaxel as first-line treatment for metastatic breast cancer (MBC) patients with HER2neu overexpression.

BOOG 2002-02/HERTAX

ISRCTN13770586

Coordinator(s)

Professor Dr J. Klijn, Dr M. Bontenbal, Dr C. Seynaeve, Erasmus MC/DDHK, P.O. Box 5201, 3008 AE ROTTERDAM, THE NETHERLANDS, Tel: +31 10 4391733 Fax: +31 10 4391003 Email: [email protected]

Summary

Indication:

Patients with MBC with HER2neu overexpression (3⁺ assessed by IHC DAKO HercepTest), previously untreated by chemotherapy, except for neoadjuvant or adjuvant (non-taxane containing) chemotherapy.

Primary Endpoints

Progression free survival, which is defined as follows:

• In the combination treatment arm: the time from start of treatment to progression or death, whichever occurs first.
• In the treatment arm with Herceptin (H) followed by Taxotere (TXT): the time from start of H treatment till progression during subsequent TXT treatment or death whichever occurs first.
• If a patient does not receive TXT once the patient progresses on or after H alone, for whatever reason, the time to progression is taken as the time to progression on or after H.
• If a patient goes off protocol treatment and receives off protocol any other hormonal treatment or chemotherapy without previous formal assessment of progression, the date of start of that other treatment is taken as the time of progression for the purpose of this study.

Secondary Endpoints

• Response rate. In the H followed by TXT arm, both the response on H and the response on TXT will be assessed.
• Overall survival measured from start of protocol treatment till date of death.

Scheme

None available

Update

• Started February 2003.

Related Publications

None available

Topics

• HER2 positive patients
• MBC
• Taxanes
• Trastuzumab

Keywords

None available

***************************************************

Title

Micro-metastases and Isolated tumour cells: Robust and Relevant Or Rubbish? The MIRROR study in BREAST CANCER.

BOOG 2003-03/ZonMW 3214

Coordinator(s)

Dr V.C.G. Tjan-Heijnen, University Medical Center, St. Radboud, Department of Medical Oncology, P.O. Box 9101, 6500 HB NIJMEGEN, THE NETHERLANDS, Tel: +31 24 3615215 Fax: +31 24 3540788 Email: [email protected]

Summary

Comparative follow-up cohort study:

• Cohort 1: 1000 patients with no axillary metastases and NO adjuvant systemic therapy.
• Cohort 2: 1000 patients with small metastases and NO adjuvant systemic therapy.
• Cohort 3: 1000 patients with small metastases WITH adjuvant systemic therapy.

Comparison of the three cohorts will provide us evidence whether the intensive program is effective. In fact, the intervention of the pathologist is being evaluated, that is, the intensive examination of the SN by serial sectioning and/or immunohistochemistry, which determines the subsequent clinical interventions:

• Cohort 1 versus 2: The prognostic relevance of small metastases (relevance of changed pathology procedure).
• Cohort 2 versus 3: To assess the impact of adjuvant therapy on disease-free survival.
• Cohort 1 + 2 versus 3: Impact of the overall program (for Cohort 3: delivery of adjuvant therapy and examinations for toxicities of

Scheme

Update

• Start 1 January 2006.

Related Publications

None available

Topics

• Sentinel node micrometastasis

Keywords

None available

***************************************************

Title

Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed.

BOOG 2004-01/Young Boost

SRCTN45066831

Coordinator(s)

Professor Dr H. Bartelink, The Netherlands Cancer Institute, AMSTERDAM, THE NETHERLANDS, Tel: +31 20 512 2120 Fax: +31 20 669 1101, Email: [email protected]

Dr L.J. Boersma, MAASTRO Clinic, HEERLEN, THE NETHERLANDS, Tel: +31 45 577 1200 Fax: +31 45 574 0277, Email: [email protected]

Professor Dr J.W. Leer, UMC Radboud, NIJMEGEN, THE NETHERLANDS, Tel: +31 24 361 4515 Fax: +31 24 356 8350, Email: [email protected]

Dr Ph. Poortmans, Dr Bernard Verbeeten Institute, TILBURG, THE NETHERLANDS, Tel: +31 13 594 7777 Fax: +31 13 468 5174, Email: [email protected]

Summary

Hypothesis:

Will 10 Gy additional boost to the tumor bed yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis for breast cancer patients less than 51 years?

Primary Outcome

• Local control at 10 year.

Secondary Outcome

• Cosmetic outcome.

Additional Objectives

• A: To test the genotypic and phenotypic profiles of breast tumors [van de Vijver et al., 2002] in young patients with invasive breast cancer, and its relation to:

        – local recurrence after BCT,

        – lymph node metastases,

        – distant metastases and surviva,

        – radiosensitivity,

        – age.

• B: To determine whether improved genotypic and phenotypic profiles can be determined related to the endpoints mentioned in A.

Scheme

Update

• Start: 1 July 2004; Expected closing: 1/7/2009.

Related Publications

van de Vijver MJ, He YD, van't Veer LJ et al. A gene-expression signature as a predictor of survival in breast cancer. N Eng J Med 2002; 347: 1999–2009.

Topics

• Loco-regional relapse
• Radiotherapy
• Young patients

Keywords

Gene expression profile, radiotherapeutic boost

***************************************************

Title

Microarray analysis in breast cancer to Tailor Adjuvant Drugs Or Regimens, a randomized phase III study. MATADOR, BOOG 2005-02, CKTO 2004-04 ISRCTN61893718

Coordinator(s)

H.M. Oosterkamp and S.C. Linn, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Departments of Molecular Carcinogenesis and Medical Oncology, Plesmanlaan 121, 1066 CX AMSTERDAM, THE NETHERLANDS, Tel: +31 20 5122951 Fax: +31 20 5122572, Email: [email protected]

Summary

Primary Objective:

• To define gene expression profiles that can predict a disease-free survival advantage for either dose dense therapy, or docetaxel – containing chemotherapy.

Secondary Objectives

• To define gene expression profiles that can predict a recurrence-free survival advantage for either dose dense therapy, or docetaxel – containing chemotherapy.
• Is TAC better than AC dd concerning DFS, RFS, breast cancer specific survival and all cause survival?

This is a prospective, non-blinded randomized phase II/III trial. A phase II feasibility study will be performed to assess accrual rate and sample collection efficiency. In the case of an accrual rate of less than 60 patients/year, the study may be stopped. Before surgery patients will be asked permission to collect tumor tissue and blood serum for possible research in the future related to their breast cancer. Only patients who appear to have node positive disease after surgery will be asked to participate in the current study. After informed consent has been obtained, they will be randomized to one of the chemotherapy arms (TAC or AC dd). Patients will be stratified according to treatment center, menopausal status (pre versus post), type of surgery (mastectomy versus lumpectomy), hormone receptor status (ER and/or PR + versus both negative), HER2 receptor status, nodal status (pN1(sn) (e.g. AMAROS study), pN1–3 versus pN4+), tumor size (pT0 + 1 versus pT2 versus pT3), and sequence of chemotherapy–radiotherapy (chemotherapy followed by radiotherapy or vice versa). At a later stage all pathology data will be reviewed centrally.

Scheme

Update

• Enrollment start: April 2004.
• Enrollment stop: April 2008 (1200 pts).

Related Publications

None available

Topics

• Anthracyclines
• Dose densification
• Node positive breast cancer
• Taxanes

Keywords

Gene expression profile

***************************************************

Title

A prospective randomised, open, multicentre, phase III study to assess different Durations of Anastrozole therapy after 2–3 years Tamoxifen as Adjuvant therapy in postmenopausal women with breast cancer. 2006-01/DATA

Coordinator(s)

Dr V.C.G. Tjan-Heijnen, University Medical Center, St. Radboud, Department of Medical Oncology, P.O. Box 9101, 6500 HB NIJMEGEN, THE NETHERLANDS, Tel: +31 24 3615215 Fax: +31 24 3540788, Email: [email protected]

Summary

Approximately 2000 postmenopausal female patients with hormone receptor positive breast cancer already receiving 2–3 years adjuvant tamoxifen therapy.

Primary Objective

• To assess the efficacy of 6 to 5 years of anastrozole compared with 3 to 2 years anastrozole after 2–3 years adjuvant tamoxifen, measured as Disease Free Survival (DFS).

Secondary Objectives

• To determine if there is a difference in outcome between patients with node positive or node negative disease at the time of diagnosis (DFS).
• To determine if there is a difference in outcome between patients with ER + PgR − disease or patients with ER + PgR + disease (DFS).
• To determine if there is a difference in outcome between patients with Her2neu negative disease or Her2neu positive disease (DFS).
• To determine if there is a difference in incidence of contralateral breast cancer in the two groups.
• To demonstrate an improvement in OS after 6 to 5 years of adjuvant treatment with anastrozole as compared with 3 to 2 years anastrozole in patients that already received 2–3 years adjuvant tamoxifen (OS).

Scheme

Update

• Proposed start: June 2006.

Related Publications

None available

Topics

• Aromatase inhibitors
• Tamoxifen
• Hormone receptor positive breast cancer

Keywords

None available

***************************************************

Title

A randomized, open-label phase III study of first line chemotherapy in elderly metastatic breast cancer patients, comparing intravenous pegylated liposomal doxorubicin with oral capecitabine; and the incorporation of a complete geriatric assessment.

2006-02/OMEGA

Coordinator(s)

Dr C. Seynaeve, Erasmus MC-Daniel den Hoed Oncological Center, ROTTERDAM, THE NETHERLANDS, Tel: +31 10 439 1754 Fax: +31 10 439 1003 Email: [email protected] / [email protected]

Dr A.N.M. Wymenga, Medisch Spectrum Twente, ENSCHEDE, THE NETHERLANDS, Tel: +31 53 487 2440 Fax: +31 53 487 3085, Email: [email protected]

Dr C. Smorenburg, Hospital Alkmaar, ALKMAAR, THE NETHERLANDS, Tel: +31 72 548 2804 Fax: +31 72 548 2061, Email: [email protected]

Professor Dr J.W.R. Nortier, Leiden University Medical Centre, LEIDEN, THE NETHERLANDS, Tel: +31 71 526 4912 Fax: +31 71 526 6760, Email: [email protected]

Summary

Female patients with metastatic breast cancer, being 65 years or older, who are eligible for first line chemotherapy will be randomized between pegylated liposomal doxorubicin (PEG doxo, 45mg/m²) (given intravenously, each 28 days), and capecitabine (2000 mg/m², days 1–14, to be repeated every 21 days).

Questionnaires regarding quality of life (QoL) and a geriatric assessment tool (GA) will be incorporated to further investigate the contribution and role of these types of assessments aiming to improve the clinical evaluation of the condition and/or frailty of the individual patient and QoL during chemotherapy in elderly metastatic breast cancer patients.

Primary Objective

• Progression free survival (PFS)

Secondary Objectives

• Objective response rate (complete responses (CR) + partial responses (PR)), in the two treatment regimens.
• Clinical benefit (CB) rate (summation of CR + PR + stable disease (SD) ≥ 24 weeks) in the two treatment regimens.
• Overall survival (OS) in the two treatment groups.
• Relation of response and toxicity of the respective chemotherapy regimen with co-morbidity and co-medication.
• The value of geriatric assessments.
• Toxicity and tolerability of the two regimens.
• Compliance of the two regimens.

Scheme

This is a randomized, open-label, multicenter study comparing PEG doxoru-bicin (CAELYX) with capecitabine (Xeloda) as first line chemotherapy in MBC patients being 65 years or older.

Patients will be randomized to one of two treatment regimens:

Group 1: PEG doxorubicin 45 mg/m², administered intravenously every 28 days, until progression, unacceptable toxicity OR six cycles (6 months of therapy).

Group 2: Capecitabine, administered at a dosage of 1000 mg/m², taken orally and twice daily (BID) for 14 consecutive days followed by a 7-day rest period. A subsequent cycle is repeated after 21 days. Therapy is continued until progressive disease, unacceptable toxicity OR eight cycles (6 months of therapy).

Update

• Start: 1 June 2006.

Related Publications

None available

Topics

• Capecitabine
• Elderly patients
• Postmenopausal patients

Keywords

Capecitabine, Caelyx, elderly patients, geriatric assessment

***************************************************

Title

BOOG participation in International studies:

BOOG 2001-01/TEAM trial

BOOG 2001-02/AMAROS (EORTC 10981/22023)

BOOG 2002-04/HERA (BIG 1-01/EORTC 10011/BO16348B)

BOOG 2003-02 (BIG 1-02/IBCSG 27-02)

BOOG 2003-04 (GBG 29)

BOOG 2004-02/TBP (GBG 26, BIG 3-05)

BOOG 2005-01/CASA (IBCSG 32-05/BIG 1-05)

BOOG 2005-03/MINDACT (EORTC 10041, BIG 3-04)

BOOG 2006-03/SUPREMO (BIG 2-04)

BOOG 2006-04/Adjuvant lapatinib study (BIG 2-06/EGF106708)