Clinical Trial: NCT03444025 - My Cancer Genome

NCT03444025

Description:

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.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Not yet recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03444025

Trial Eligibility

Document

Title

Brief Title: 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

Clinical Trial IDs

ORG STUDY ID: B2017-11
NCT ID: NCT03444025

Conditions

Breast Cancer Triple Negative

Interventions

Drug	Synonyms	Arms
Goserelin	Zoladex	Group A

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
Group A	Experimental	Goserelin 3.6 mg depot injection will be administered subcutaneously every month along with standard chemotherapy regimen: AC-P: Doxorubicin 60 mg/m2 IV plus cyclophosphamide 600 mg/m2 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 by 1 hour infusion every week for 12 weeks. Each cycle is 21 days.	Goserelin
Group B	No Intervention	Standard chemotherapy regimen: AC-P: Doxorubicin 60 mg/m2 IV plus cyclophosphamide 600 mg/m2 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 by 1 hour infusion every week for 12 weeks. Each cycle is 21 days.

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).

Maximum Eligible Age:	60 Years
Minimum Eligible Age:	18 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	pathologic complete response rate
Time Frame:	6 months
Safety Issue:
Description:	The primary endpoint will be the pathologic complete response rate (pCR), defined as no residual invasive tumor in both the breast and axilla (and including in situ residual; ypT0/is, ypN0).

Secondary Outcome Measures

Measure:	LHRH-positive and/or AR-positive Rate
Time Frame:	6 months
Safety Issue:
Description:	Incidence of LHRH-positive and/or AR-positive cases among TNBC

Measure:	Relapse-free Survival
Time Frame:	3 years
Safety Issue:
Description:	Estimated 3 years RFS rates in the 2 arms (RFS events will include locoregional recurrence, distant recurrence, contralateral breast cancer and death from any cause).

Measure:	Objective response rate
Time Frame:	6 months
Safety Issue:
Description:	Clinical and radiological ORRs

Measure:	Adverse events
Time Frame:	6 months
Safety Issue:
Description:	All grade and high grade adverse events rate in both arms

Measure:	Ovarian failure rate
Time Frame:	2 years
Safety Issue:
Description:	Ovarian failure rates at 2 years in both groups (defined as the absence of menses in the preceding 6 months and levels of follicle-stimulating hormone (FSH) in the postmenopausal range).

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Not yet recruiting
Lead Sponsor:	Kasr El Aini Hospital

Last Updated

February 23, 2018

Clinical Trials /

Neoadjuvant Goserelin for Triple Negative Breast Cancer