Concurrent chemo-endocrine treatment in hormone receptor positive breast cancer compared to sequential administration of the same
Phase 3
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2018/09/015643
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Non-metastatic, biopsy proven breast cancer
2.ER and/or PR positive
3.HER2 negative
4.Age > 18 yrs
5.Fit to receive chemotherapy
6.Written, informed consent
7.Planned to receive both chemo and endocrine therapy in the adjuvant or neo-adjuvant setting
Exclusion Criteria
1.Pregnant or lactating women
2.Patients who are candidates to receive only endocrine treatment (low risk of recurrence)
3.Inflammatory breast carcinoma
4.Women who have received prior chemo/hormonal therapy for breast cancer
5.Co-existing non-breast malignancy (such as hematolymphoid/ovarian cancer)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the improvement in disease free survival by administering concurrent versus sequential, (neo) adjuvant chemo-endocrine therapy in hormone receptor positive, HER2 negative, non-metastatic breast cancerTimepoint: 5 years
- Secondary Outcome Measures
Name Time Method To assess improvement in overall survival, toxicity profile between the 2 treatment arms, pathological complete response rates in the neo-adjuvant setting ,Surgical resectability rate post neoadjuvant therapy in LABC, For any difference in the breast conservation rate in the neo-adjuvant setting, The efficacy of ovarian suppression with the 3 monthly ovarian suppression/ LHRHa by doing analysis of E2/FSH in premenopausal women. This will be done in at least the first 100 patients in each arm.Timepoint: 5 years