Clinical Trials /

Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer

NCT03499353

Description:

A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE NEGATIVE BREAST CANCER

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer
  • Official Title: A Phase 2, Non-randomized, Open Label, Single Arm, Multi-center Study Of Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: C3441020
  • SECONDARY ID: TALAZOPARIB NEOADJ BC
  • NCT ID: NCT03499353

Conditions

  • Early Breast Cancer

Interventions

DrugSynonymsArms
TALAZOPARIBTALAZOPARIB

Purpose

A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE NEGATIVE BREAST CANCER

Detailed Description

      TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS
      WITH EARLY TRIPLE NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED
      BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.
    

Trial Arms

NameTypeDescriptionInterventions
TALAZOPARIBExperimentalSINGLE ARM, NON-RANDOMIZED
  • TALAZOPARIB

Eligibility Criteria

        Inclusion Criteria:

          -  Germline BRCA 1/2 Mutation Positive

          -  Women and men at least 18 years of age or older.

          -  Histologically confirmed invasive triple negative Breast Cancer

          -  Tumor >1.5 cm.

          -  No evidence of distant metastasis

          -  Adequate bone marrow, hepatic, and renal function

          -  ECOG performance status 0 or 1

        Exclusion Criteria:

          -  Any previous antitumor therapies for the current cancer event

          -  Evidence of distant metastasis apparent prior to randomization

          -  Patients with inflammatory breast carcinoma

          -  Malignancy within the last 3 years

          -  Previous or concomitant systemic anti cancer therapies used for the treatment of
             cancer in the last 3 years.

          -  Prior treatment with a PARP inhibitor in any disease setting

          -  Concomitant use of P gp inhibitors or inducers or BCRP inhibitors

          -  Patients who are unwilling or unable to use 2 highly effective methods of
             contraception as outlined in this protocol

          -  Major surgery within 14 days prior to study entry

          -  No known history of cardiovascular disease

          -  Active clinically significant infection

          -  Clinically significant bleeding diathesis or coagulopathy

          -  Non healing wound, ulcer or bone fracture

          -  Known hypersensitivity to any of the components of talazoparib

          -  Patients with myelodysplastic syndrome/acute myeloid leukemia

          -  Patients with uncontrolled seizures.

          -  Any evidence of other disease or any concomitant medical or psychiatric problems which
             in the opinion of the Investigator would prevent completion of treatment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathological Complete Response (pCR) by Independent Central Reviewer(ICR)
Time Frame:Following the completion of 24 weeks of Talazoparib Treatment
Safety Issue:
Description:Pathological Complete Response(pCR) by Independent Central Reviewer (ICR) defined by: defined as ypT0, ypN0 (the absence of residual invasive and in situ cancer on evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy).

Secondary Outcome Measures

Measure:pCR by Investigator
Time Frame:Following the completion of 24 weeks of Talazoparib Treatment
Safety Issue:
Description:pCR rate by investigator is defined as the number and percentage of patients achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all patients in the evaluable population.
Measure:Residual Cancer Burden(RCB) by Independent reviewer
Time Frame:Following the completion of 24 weeks of Talazoparib Treatment
Safety Issue:
Description:Residual cancer burden by ICR will be reported as a categorical variable with four classes (categories) RCB 0 (pCR), I (minimal RCB), II (moderate RCB), and III (extensive RCB).
Measure:pCR by independent Reviewer in Breast
Time Frame:Following the completion of 24 weeks of Talazoparib Treatment
Safety Issue:
Description:pCR rate in breast by ICR is defined as the number and percentage of patients achieving pCR in breast by independent central review after talazoparib treatment for 24 weeks, followed by surgery, among all patients in the evaluable population
Measure:Event Free Survival
Time Frame:Time of Surgery up to 36 months
Safety Issue:
Description:Time of surgery to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse
Measure:Overall Survival
Time Frame:First Dose of Talazoparib up to 42 months
Safety Issue:
Description:Time from the first dose of Talazoparib to death due to any cause
Measure:Incidence of Adverse Events
Time Frame:Upon signing Informed Consent up to 42 months
Safety Issue:
Description:Type, incidence, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v4.03), seriousness and relationship of study medications to adverse events (AE) and any laboratory abnormalities
Measure:Patient Reported Outcome: Deterioration of Global Health Status
Time Frame:First dose of Talazoparib up to 9 months
Safety Issue:
Description:Time to definitive deterioration of Global Health Status per EORTC QLQ-C30
Measure:Patient Reported Outcome: Nausea and vomiting symptoms
Time Frame:First dose of Talazoparib up to 9 months
Safety Issue:
Description:Time to definitive deterioration in nausea and vomiting symptoms per EORTC QLQ C30
Measure:Patient Reported Outcome: global health status/QoL, functioning, and symptoms
Time Frame:First dose of Talazoparib up to 9 months
Safety Issue:
Description:Change from baseline in global health status/QoL, functioning, and symptoms per EORTC QLQ C30 and EORTC QLQ BR 23
Measure:Patient Reported Outcome- Antiemetic Log
Time Frame:First dose of Talazoparib up to 9 months
Safety Issue:
Description:Proportion of patients with deterioration, improvement and no change in nausea and vomiting symptoms.
Measure:Patient Reported Outcome: Missed Menstrual Period
Time Frame:First dose of Talazoparib up to 9 months
Safety Issue:
Description:Change from baseline in proportion of patients with missed expected menstrual period per PRO CTCAE
Measure:Pharmacokenetic assessment of Talazoparib
Time Frame:week 4, week 8, week 12
Safety Issue:
Description:Plasma concentration of talazoparib

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Pfizer

Trial Keywords

  • Neoadjuvant Therapy, Triple Negative Breast Cancer, BRACA Positive

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