NCT03444025

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2018

Longer than P75 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

3 years

First QC Date

February 18, 2018

Last Update Submit

February 18, 2018

Conditions

Breast Cancer Triple Negative

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • LHRH-positive and/or AR-positive Rate

    6 months

  • Relapse-free Survival

    3 years

  • Objective response rate

    6 months

  • Adverse events

    6 months

  • Ovarian failure rate

    2 years

Study Arms (2)

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.

Drug: 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.

Interventions

GoserelinDRUG

Goserelin is Luteinizing hormone releasing hormone (LHRH) analogue.

Also known as: Zoladex
Group A

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Central Study Contacts

Kyrillus S Shohdy, MD

CONTACT

02 01229961016shohdyks@residents.kasralainy.edu.eg

Loay Kassem, MD

CONTACT

02 01003022907loay.kassem@cairocure.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 18, 2018

First Posted

February 23, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2021

Study Completion

March 1, 2023

Last Updated

February 23, 2018

Record last verified: 2018-02