ISRCTN23561723CompletedNot Applicable
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
Breast Cancer Study Group (BOOG) (The Netherlands)0 sites25 target enrollmentStarted: December 19, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
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)
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)
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