Clinical trial NCT03444025: Neoadjuvant Goserelin for Triple Negative Breast Cancer
Official title: Prospective Phase II Randomized Trial of Evaluating the Effect of Adding LHRH Analogue to the Neoadjuvant Chemotherapy Treatment of Triple Negative Breast Cancer on Pathologic Complete Response (pCR) Rates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer Triple Negative
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 pathologic complete response (pCR) in tumor and lymph nodes, pCR is proofed to be a surrogate and reliable predictive factor of survival rates in TNBC. This study will evaluate the effect of adding LHRH analogue, goserelin, to the standard neoadjuvant chemotherapy. Following completion of neoadjuvant therapy, patients will undergo breast conservative surgery or mastectomy. Post-neoadjuvant chemotherapy axillary staging will be required, but the choice of the procedure will be at the physician's discretion. Postoperative radiation therapy will be given at the physician's discretion. The use of partial breast irradiation techniques will not be allowed. The primary endpoint will be the rate of pathologic complete response. The secondary endpoints will be 3-year-disease free survival, clinical response and toxicity. Exploratory endpoints will be correlation of the LHRH receptor expression level with the pCR. The sample size for the trial will be 180 patients accrued over a period of 2 years. Definitive analysis of the primary endpoints is expected at year 3.

Eligibility 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).

Primary outcomes:
measure: pathologic complete response rate
timeFrame: 6 months
Secondary outcomes:
measure: LHRH-positive and/or AR-positive Rate
timeFrame: 6 months
measure: Relapse-free Survival
timeFrame: 3 years
measure: Objective response rate
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
measure: Ovarian failure rate
timeFrame: 2 years
Other outcomes:
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