Neoadjuvant Goserelin for Triple Negative Breast Cancer

Breast Cancer Triple Negative Clinical Trial

— NeoGONT  

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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03444025
• Other study ID #: B2017-11
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 18, 2018
• Last updated: February 18, 2018
• Start date: March 2018
• Est. completion date: March 2023

Study information

• Verified date: February 2018
• Source: Kasr El Aini Hospital
• Contact: Kyrillus S Shohdy, MD
• Phone: 02 01229961016
• Email: shohdyks[@]residents.kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: March 2023
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer Triple Negative
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Goserelin
Goserelin is Luteinizing hormone releasing hormone (LHRH) analogue.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response rate	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).	6 months
Secondary	LHRH-positive and/or AR-positive Rate	Incidence of LHRH-positive and/or AR-positive cases among TNBC	6 months
Secondary	Relapse-free Survival	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).	3 years
Secondary	Objective response rate	Clinical and radiological ORRs	6 months
Secondary	Adverse events	All grade and high grade adverse events rate in both arms	6 months
Secondary	Ovarian failure rate	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).	2 years