Neoadjuvant Goserelin for Triple Negative Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Female

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 LHRH might decrease resistance to chemotherapeutic agents in the neoadjuvant setting and increases clinical and pathological response rates. Additionally, exploring potential surrogate markers (as AR and LHRH receptors) for molecular distinct subtypes of TNBC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kasr El Aini Hospital
• Treatments: Goserelin

Criteria

Inclusion Criteria:

1. Premenopausal women between 18 and 60 years.

2. Histologically proven, newly diagnosed invasive carcinoma of breast.

3. Tumors must be ER, PgR negative and HER2-neu negative.

4. Stage II or III breast cancer that is indicated for neoadjuvant systemic chemotherapy.

Exclusion Criteria:

1. pregnant females at time of diagnosis of breast cancer.

2. bilateral breast cancer.

3. already received treatment for breast cancer including surgery, radiation, cytotoxic, or endocrine therapy

4. history or concomitant diagnosis of another primary malignancy.

5. concurrent treatment with oral contraceptives or hormone replacement therapy (OCPs or HRT must be stopped at least 4 weeks prior to randomization).