Neoadjuvant Goserelin for Triple Negative Breast Cancer

NCT ID: NCT03444025

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2023-03-31

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.

Conditions

Breast Cancer Triple Negative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

Goserelin

Intervention Type: DRUG

Goserelin is Luteinizing hormone releasing hormone (LHRH) analogue.

Group B

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Goserelin

Goserelin is Luteinizing hormone releasing hormone (LHRH) analogue.

Intervention Type: DRUG

Other Intervention Names

Zoladex

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyrillus S Shohdy

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kyrillus S Shohdy, MD

Role: CONTACT

shohdyks@residents.kasralainy.edu.eg

02 01229961016

Loay Kassem, MD

Role: CONTACT

loay.kassem@cairocure.com

02 01003022907

Other Identifiers

B2017-11

Identifier Type: -

Identifier Source: org_study_id