Status:
UNKNOWN
Neoadjuvant Goserelin for Triple Negative Breast Cancer
Lead Sponsor:
Kasr El Aini Hospital
Conditions:
Breast Cancer Triple Negative
Eligibility:
FEMALE
18-60 years
Phase:
PHASE2
Brief Summary
This is a phase II randomized trial that will evaluate the effect of adding LHRH analogue, goserelin, to the standard neoadjuvant chemotherapy to patients with triple negative breast cancer. Targeting...
Detailed Description
Neoadjuvant chemotherapy (NACT) is the mainstay of treatment of locally advanced TNBC and some selected early cases followed by surgery with or without adjuvant radiotherapy. NACT is aimed to induce p...
Eligibility Criteria
Inclusion
- Premenopausal women between 18 and 60 years.
- Histologically proven, newly diagnosed invasive carcinoma of breast.
- Tumors must be ER, PgR negative and HER2-neu negative.
- Stage II or III breast cancer that is indicated for neoadjuvant systemic chemotherapy.
Exclusion
- pregnant females at time of diagnosis of breast cancer.
- bilateral breast cancer.
- already received treatment for breast cancer including surgery, radiation, cytotoxic, or endocrine therapy
- history or concomitant diagnosis of another primary malignancy.
- concurrent treatment with oral contraceptives or hormone replacement therapy (OCPs or HRT must be stopped at least 4 weeks prior to randomization).
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03444025
Start Date
March 1 2018
End Date
March 1 2023
Last Update
February 23 2018
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