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History of Changes for Study: NCT03499353
Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer
Latest version (submitted October 11, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 9, 2018 None (earliest Version on record)
2 April 25, 2018 Study Status
3 July 31, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 August 2, 2018 Study Status and Contacts/Locations
5 August 5, 2018 Contacts/Locations and Study Status
6 August 7, 2018 Contacts/Locations and Study Status
7 August 21, 2018 Contacts/Locations and Study Status
8 August 31, 2018 Study Status and Contacts/Locations
9 September 7, 2018 Contacts/Locations and Study Status
10 September 11, 2018 Contacts/Locations and Study Status
11 September 24, 2018 Contacts/Locations and Study Status
12 October 1, 2018 Study Status and Contacts/Locations
13 October 4, 2018 Contacts/Locations and Study Status
14 October 18, 2018 Contacts/Locations and Study Status
15 October 22, 2018 Contacts/Locations and Study Status
16 November 1, 2018 Contacts/Locations and Study Status
17 November 3, 2018 Contacts/Locations and Study Status
18 November 7, 2018 Contacts/Locations and Study Status
19 November 12, 2018 Contacts/Locations and Study Status
20 November 16, 2018 Contacts/Locations and Study Status
21 November 22, 2018 Contacts/Locations and Study Status
22 November 26, 2018 Contacts/Locations and Study Status
23 January 25, 2019 Contacts/Locations, Study Status, Eligibility and Outcome Measures
24 February 25, 2019 Contacts/Locations, IPDSharing, Study Status and Study Identification
25 March 14, 2019 Contacts/Locations and Study Status
26 April 12, 2019 Contacts/Locations and Study Status
27 May 2, 2019 Contacts/Locations and Study Status
28 May 30, 2019 Contacts/Locations and Study Status
29 June 14, 2019 Contacts/Locations and Study Status
30 July 24, 2019 Contacts/Locations and Study Status
31 August 6, 2019 Study Status and Contacts/Locations
32 December 3, 2019 Contacts/Locations, Study Status, Study Description, Study Identification, References, Eligibility, Study Design and Conditions
33 December 13, 2019 Study Status and Contacts/Locations
34 January 28, 2020 Study Status and Contacts/Locations
35 February 19, 2020 Contacts/Locations and Study Status
36 March 19, 2020 Contacts/Locations and Study Status
37 April 20, 2020 Contacts/Locations and Study Status
38 May 26, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
39 June 15, 2020 Study Status and Study Design
40 August 11, 2020 Study Status, Study Design and Study Identification
41 October 23, 2020 Recruitment Status, Study Status and Study Design
42 November 20, 2020 Contacts/Locations and Study Status
43 March 22, 2021 Contacts/Locations and Study Status
44 August 20, 2021
Quality Control Review has not concluded Returned: September 16, 2021
Outcome Measures, Study Status, Document Section and Conditions
45 October 11, 2021 Outcome Measures, Study Status, Adverse Events, Baseline Characteristics
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Study NCT03499353
Submitted Date:  April 9, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: C3441020
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
Secondary IDs: TALAZOPARIB NEOADJ BC [Alias Study Number]
Open or close this module Study Status
Record Verification: April 2018
Overall Status: Not yet recruiting
Study Start: April 26, 2018
Primary Completion: October 25, 2020 [Anticipated]
Study Completion: February 25, 2023 [Anticipated]
First Submitted: April 9, 2018
First Submitted that
Met QC Criteria:
April 9, 2018
First Posted: April 17, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
April 9, 2018
Last Update Posted: April 17, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Pfizer
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
Open or close this module Conditions
Conditions: Early Breast Cancer
Keywords: Neoadjuvant Therapy, Triple Negative Breast Cancer, BRACA Positive
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
THIS IS AN OPEN LABEL SINGLE ARM STUDY
Number of Arms: 1
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 122 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: TALAZOPARIB
SINGLE ARM, NON-RANDOMIZED
Drug: TALAZOPARIB
Talazoparib 1mg/day
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Pathological Complete Response (pCR) by Independent Central Reviewer(ICR)
[ Time Frame: Following the completion of 24 weeks of Talazoparib Treatment ]

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:
1. pCR by Investigator
[ Time Frame: Following the completion of 24 weeks of Talazoparib Treatment ]

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.
2. Residual Cancer Burden(RCB) by Independent reviewer
[ Time Frame: Following the completion of 24 weeks of Talazoparib Treatment ]

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).
3. pCR by independent Reviewer in Breast
[ Time Frame: Following the completion of 24 weeks of Talazoparib Treatment ]

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
4. Event Free Survival
[ Time Frame: Time of Surgery up to 36 months ]

Time of surgery to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse
5. Overall Survival
[ Time Frame: First Dose of Talazoparib up to 42 months ]

Time from the first dose of Talazoparib to death due to any cause
6. Incidence of Adverse Events
[ Time Frame: Upon signing Informed Consent up to 42 months ]

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
7. Patient Reported Outcome: Deterioration of Global Health Status
[ Time Frame: First dose of Talazoparib up to 9 months ]

Time to definitive deterioration of Global Health Status per EORTC QLQ-C30
8. Patient Reported Outcome: Nausea and vomiting symptoms
[ Time Frame: First dose of Talazoparib up to 9 months ]

Time to definitive deterioration in nausea and vomiting symptoms per EORTC QLQ C30
9. Patient Reported Outcome: global health status/QoL, functioning, and symptoms
[ Time Frame: First dose of Talazoparib up to 9 months ]

Change from baseline in global health status/QoL, functioning, and symptoms per EORTC QLQ C30 and EORTC QLQ BR 23
10. Patient Reported Outcome- Antiemetic Log
[ Time Frame: First dose of Talazoparib up to 9 months ]

Proportion of patients with deterioration, improvement and no change in nausea and vomiting symptoms.
11. Patient Reported Outcome: Missed Menstrual Period
[ Time Frame: First dose of Talazoparib up to 9 months ]

Change from baseline in proportion of patients with missed expected menstrual period per PRO CTCAE
12. Pharmacokenetic assessment of Talazoparib
[ Time Frame: week 4, week 8, week 12 ]

Plasma concentration of talazoparib
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Supporting Information:
Time Frame:
Access Criteria:
URL:

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