Immediate optimal endocrine adjuvant therapy versus standard chemotherapy followed by the same endocrine therapy in pre- or peri-menopausal patients with early hormone receptor-positive breast cancer - the Promise study
| ISRCTN | ISRCTN23561723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23561723 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 24/08/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof J.G.M. Klijn
Scientific
Scientific
Erasmus Medical Center
Daniel den Hoed Kliniek
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 4391733 |
|---|---|
| j.g.m.klijn@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PROMISE, BOOG 2002-01 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Goserelin, anastrozole |
| Primary outcome measure | 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 study start date | 01/07/2005 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 25 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3008 AE
Netherlands
3008 AE
Netherlands
Sponsor information
Breast Cancer Study Group (BOOG) (The Netherlands)
Not defined
Not defined
P.O. Box 9236
Amsterdam
1006 AE
Netherlands
| Phone | +31 (0)20 3462547 |
|---|---|
| boog@ikca.nl | |
"ROR" |
https://ror.org/04cr37s66 |
Funders
Funder type
Industry
CKTO, Astra Zeneca
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
