A Phase III,Randomized,Open Label Study Comparing Simultaneous Versus Sequential Use of Adjuvant Chemotherapy and GnRHa up to 2-3 Years for ≤ 45 Year Old Pre-menopausal Hormone Receptor-positive Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- Zoladex
- Conditions
- Breast Cancer
- Sponsor
- Fudan University
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Resumption of menstruation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The present study is a randomized open-label -phase III study that aims to compare the efficacy and safety of the adjuvant chemotherapy with simultaneous or sequential application of Zoladex up to 2-3 years for ≤ 45 year old premenopausal hormone receptor-positive breast cancer.
Detailed Description
Data showed that ovarian suppression therapy may protect the ovarian function in premenopausal patients received chemotherapy for breast cancer. However this is still a controversial issue. Sequential use of GnRHa (Zoladex) as ovarian suppression treatment after chemotherapy has been established as an effective endocrine therapy for ER positive premenopausal breast cancer. The present study is a randomized open-label phase III study that aims to observe the efficacy and safety of the adjuvant chemotherapy with simultaneous combination of Zoladex up to 2-3years and chemotherapy compared with the sequential schedule in ≤ 45 year old premenopausal hormone receptor-positive breast cancer patients.
Investigators
Zhimin Shao
Director of Department of Surgical Oncology,Cancer Hospital & Institute
Fudan University
Eligibility Criteria
Inclusion Criteria
- •Primary invasive breast cancer pathologically approved by core needle or open biopsy
- •Patients must have undergone standard surgery for primary breast cancer as shown in the following:
- •mastectomy
- •breast conservation surgery followed by whole breast radiation
- •axillary dissection or sentinel node biopsy
- •Need adjuvant chemotherapy after surgery
- •Patients taking neo-chemotherapy are eligible
- •Patients with synchronous bilateral cancers are eligible on the condition that If one side is IDC and the other side is DCIS, the IDC side should be of the ER and/or PR positive phenotype and IF two sides are both IDC, they must be ER and/or PR positive phenotype at the same time
- •Hormone receptor positive (≥＋) is defined as detecting ER or PR expression at any time is eligible. The situation of only PR positive and ER negative is eligible, too
- •Based on the study objective, all patients are required to be premenopausal as defined by
Exclusion Criteria
- •patients with metastatic malignant tumor
- •previous history of asynchronous bilateral breast cancer
- •any previous malignancy in the past 5 years, except for those treated with curative intent, such as carcinoma in situ of the cervix, squamous carcinoma of the skin or basal cell carcinoma of the skin
- •any non-malignant systemic disease which interfere long time follow up
- •history of medical ovarian ablation therapy
- •severe live dysfunction, Child-Pugh is grade C
- •Severe renal dysfunction
- •Occult breast cancer
- •severe heart dysfunction, heart functional classification is above Class III
Arms & Interventions
Zoladex combined with chemotherapy
After signing informed consent, patients will be screened, eligible patients were randomly divided into 2 groups, the test group should use Zoladex 3.6mg once a month up to 2-3 years combined with chemotherapy,all patients will receive Tamoxifen after chemotherapy
Intervention: Zoladex
Zoladex after chemotherapy
After signing informed consent, patients will be screened, eligible patients were randomly divided into 2 groups, the control group should use Zoladex 3.6mg once a month up to 2-3 years after chemotherapy,all patients will receive Tamoxifen after chemotherapy
Intervention: Zoladex
Outcomes
Primary Outcomes
Resumption of menstruation
Time Frame: 1 year
the Resumption that patients recover the natural menstrual or serum E2, FSH, LH return to the premenopausal range within 1 year after stopping Zoladex
Secondary Outcomes
- OS(5 years)
- Other adverse events(5years)
- RFS(5years)