Neoadjuvant Goserelin for Triple Negative Breast Cancer (NeoGONT)
Primary Purpose
Breast Cancer Triple Negative
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Goserelin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Triple Negative
Eligibility Criteria
Inclusion Criteria:
- Premenopausal women between 18 and 60 years.
- Histologically proven, newly diagnosed invasive carcinoma of breast.
- Tumors must be ER, PgR negative and HER2-neu negative.
- Stage II or III breast cancer that is indicated for neoadjuvant systemic chemotherapy.
Exclusion Criteria:
- pregnant females at time of diagnosis of breast cancer.
- bilateral breast cancer.
- already received treatment for breast cancer including surgery, radiation, cytotoxic, or endocrine therapy
- history or concomitant diagnosis of another primary malignancy.
- concurrent treatment with oral contraceptives or hormone replacement therapy (OCPs or HRT must be stopped at least 4 weeks prior to randomization).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A
Group B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
LHRH-positive and/or AR-positive Rate
Incidence of LHRH-positive and/or AR-positive cases among TNBC
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).
Objective response rate
Clinical and radiological ORRs
Adverse events
All grade and high grade adverse events rate in both arms
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).
Full Information
NCT ID
NCT03444025
First Posted
February 18, 2018
Last Updated
February 18, 2018
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03444025
Brief Title
Neoadjuvant Goserelin for Triple Negative Breast Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Triple Negative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Goserelin
Other Intervention Name(s)
Zoladex
Intervention Description
Goserelin is Luteinizing hormone releasing hormone (LHRH) analogue.
Primary Outcome Measure Information:
Title
pathologic complete response rate
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
LHRH-positive and/or AR-positive Rate
Description
Incidence of LHRH-positive and/or AR-positive cases among TNBC
Time Frame
6 months
Title
Relapse-free Survival
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).
Time Frame
3 years
Title
Objective response rate
Description
Clinical and radiological ORRs
Time Frame
6 months
Title
Adverse events
Description
All grade and high grade adverse events rate in both arms
Time Frame
6 months
Title
Ovarian failure rate
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).
Time Frame
2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal women between 18 and 60 years.
Histologically proven, newly diagnosed invasive carcinoma of breast.
Tumors must be ER, PgR negative and HER2-neu negative.
Stage II or III breast cancer that is indicated for neoadjuvant systemic chemotherapy.
Exclusion Criteria:
pregnant females at time of diagnosis of breast cancer.
bilateral breast cancer.
already received treatment for breast cancer including surgery, radiation, cytotoxic, or endocrine therapy
history or concomitant diagnosis of another primary malignancy.
concurrent treatment with oral contraceptives or hormone replacement therapy (OCPs or HRT must be stopped at least 4 weeks prior to randomization).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyrillus S Shohdy, MD
Phone
02 01229961016
Email
shohdyks@residents.kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Loay Kassem, MD
Phone
02 01003022907
Email
loay.kassem@cairocure.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Neoadjuvant Goserelin for Triple Negative Breast Cancer
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