Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
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
Overall study end date
31/12/2011
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Not Specified
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|