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Neoadjuvant Goserelin for Triple Negative Breast Cancer (NeoGONT)

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ClinicalTrials.gov Identifier: NCT03444025
Recruitment Status : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Kyrillus S Shohdy, Kasr El Aini Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Triple Negative Drug: Goserelin Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Goserelin
Goserelin is Luteinizing hormone releasing hormone (LHRH) analogue.
Other Name: Zoladex
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  1. pathologic complete response rate [ Time Frame: 6 months ]
    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 :
  1. LHRH-positive and/or AR-positive Rate [ Time Frame: 6 months ]
    Incidence of LHRH-positive and/or AR-positive cases among TNBC

  2. Relapse-free Survival [ Time Frame: 3 years ]
    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. Objective response rate [ Time Frame: 6 months ]
    Clinical and radiological ORRs

  4. Adverse events [ Time Frame: 6 months ]
    All grade and high grade adverse events rate in both arms

  5. Ovarian failure rate [ Time Frame: 2 years ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-representation of gender identity
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444025


Contacts
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Contact: Kyrillus S Shohdy, MD 02 01229961016 shohdyks@residents.kasralainy.edu.eg
Contact: Loay Kassem, MD 02 01003022907 loay.kassem@cairocure.com

Sponsors and Collaborators
Kasr El Aini Hospital
More Information
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Responsible Party: Kyrillus S Shohdy, Dr., Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03444025    
Other Study ID Numbers: B2017-11
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents