Condition category
Cancer
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
24/08/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof J.G.M. Klijn

ORCID ID

Contact details

Erasmus Medical Center
Daniel den Hoed Kliniek
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391733
j.g.m.klijn@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PROMISE, BOOG 2002-01

Study hypothesis

To compare the efficacy and tolerability of immediate optimal endocrine adjuvant therapy versus standard chemotherapy (five courses FE90C) followed by the same endocrine therapy in pre- and peri-menopausal patients with ER and/or PR positive primary breast cancer.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

A: goserelin + anastrozole for 5 years (experimental arm)
B: 5 courses of FEC90 followed by goserelin + anastrozole for five years
Goserelin is available as four weeks depot (Zoladex 3.6 mg) and as three month depot (Zoladex 10.8 mg). Zoladex 3.6 mg depot will be administered subcutaneously every 28 days. The Zoladex 10.8 mg depot will be administered every 12 weeks.
Anastrozole 1 mg/day
FEC90 (standard dose, day 1, every 21 days): Cyclophosphamide 500 mg/m^2 intravenously (iv) (push), Epidoxorubicine 90 mg/m^2 iv (push), 5-Fluorouracil 500 mg/m^2 iv (push)

Intervention type

Drug

Phase

Not Specified

Drug names

Goserelin, anastrozole

Primary outcome measures

Relapse-free survival (RFS)

Secondary outcome measures

1. Overall survival (OS), the incidence of contralateral breast cancer
2. Safety and longterm tolerability of both treatment regimens

Overall trial start date

01/07/2005

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pre-/peri-menopausal patients aged less than 60 years at entry of the trial. Patients must have had their last menstrual period less than two years before surgery of the primary tumor. In previously hysterectomised patients, women with both post-menopausal plasma Follicle Stimulating Hormone (FSH) and estradiol concentrations will be excluded.
1.a. Any N+ subgroup (N1-3, N4-9, N10)
b. Any high-risk N0 subgroup which meets one of the following criteria:
i. Tumor size more than or equal to 3 cm
ii. Tumor size 2-3 cm with grade II or III
iii. Tumor size 1-2 cm with grade III
iv. Patients under 35 years of age (with exception in case of tumors less than or equal to 1 cm, grade I)
3. Estradiol Receptors (ER) and Progesterone Receptors (PgR)status positive as defined by local hospital criteria (as cut-off levels are advised minimally more than or equal to 10% positively staining tumor cell by immunohistochemistry or more than or equal to 10 fmol/mg protein by ligand binding assay). ER-positive, PgR-negative patients are eligible
4. Patients with either Her2/neu negative or positive tumors are eligible
5. No previous systemic therapy for breast cancer
6. Adequate hematological-, renal- and hepatic function (defined as PLT more than 100 x 10^9/l, white blood cell count (WBC) more than 3 x 10^9/l, Creatinine less than 1.5 Upper Normal Limit (UNL) and SGOT (Aspartate Aminotransferase [AST]) or SGPT (Alanine Aminotrasferase [ALT]) less than 2.5 UNL)
7. Accessible for follow-up for the duration of the trial
8. Eastern Cooperative Oncology Group (ECOG) performance status zero or one
9. Written informed consent (according to International Conference on Harmonisation [ICH]/Good Clinical Practice [GCP] and local Institutional Review Board [IRB] guidelines)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

25

Participant exclusion criteria

Those patients who did not undergo intended curative primary treatment or who fulfilled one of the following criteria:
1. Inflammatory breast cancer
2. Positive supraclavicular nodes
3. Ulceration/infiltration of local skin metastasis
4. Primary surgery was completed more than 12 weeks before starting the randomised treatment
5. Both ER negative and PgR negative primary tumor
6. Evidence of distant metastases (M1)
7. Patients who have received previous systemic endocrine and/or chemotherapeutic treatment for breast cancer
8. Uncontrolled cardiac disease including unstable angina, Chronic Heart Failure (CHF) or arrhythmia requiring medical therapy or with a history of myocardial infarction within the past three months or any other serious concomitant disease
9. Psychiatric disorders preventing proper informed consent
10. Tumor with a size less than 1cm and N0 and age more than 35 years
11. Tumor size 1-2 cm, N0 with grade I or II and age over 35 years
12. Tumor size 2-3 cm, N0 with grade I and age over 35 years
13. Concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal squamous cell carcinoma of the skin, unless agreed by the Steering Committee. Subjects with other malignancies must be disease-free for at least five years. Patients with a history of breast cancer should be excluded
14. Other serious illnesses that may interfere with subject compliance, adequate informed consent or determination of causality of adverse events
15. Patients who are using contraceptive pills or receiving any Hormone Replacement Therapy (HRT) for treatment of peri-/post-menopausal symptoms should stop taking these endocrine agents at least four weeks prior to randomisation
16. Pregnancy or breast feeding
17. In case a germline BRCA1 or BRCA2 mutation is known in the family of the patient, it is advised not to include such patients in the study because of the different management of these patients and the increased risks of contralateral breast cancer and ovarian cancer (it is not warranted to perform standardly a Deoxyribonucleic Acid (DNA) test within the context of this trial)

Recruitment start date

01/07/2005

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3008 AE
Netherlands

Sponsor information

Organisation

Breast Cancer Study Group (BOOG) (The Netherlands)

Sponsor details

P.O. Box 9236
Amsterdam
1006 AE
Netherlands
+31 (0)20 3462547
boog@ikca.nl

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

CKTO, Astra Zeneca

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes