A Study to Learn About the Safety of TALZENNA for the Treatment of Breast Cancer

NCT06735742 · tracked via the Priya Life Science Japan tracker

Sponsor

Pfizer

Phase

Observational

Started

2025-04-12

Last updated

2025-11-17

Condition(s) studied

Breast Cancer

Study summary

The purpose of this study is to learn about the safety of TALZENNA for the patients with breast cancer that cannot be removed by surgery and has come back. These participants also have a past treatment with medicines that try to stop the growth of cancer cells.

This study is seeking for participants who:

* have breast cancer that cannot be removed by surgery and has come back
* have not used this medicine before. All patients in this study will receive TALZENNA according to the prescriptions.

Patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (Day 1). However, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.

Eligibility

Sex

ALL

Min age

0 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with BRCA mutation-positive and HER2- negative unresectable or recurrent breast cancer with a history of cancer chemotherapy * No history of previous use of this drug Exclusion Criteria: * None

Primary outcome measure(s)

Incidence of adverse drug reactions — Up to 52 weeks
For adverse drug reactions corresponding to myelosuppression, interstitial lung disease, thromboembolism, and secondary malignant tumour, the incidence, time of onset, grade, outcome etc. will be tabulated.

Trial sites (1)

Facility	City	Region	Status
Pfizer Japan	Tokyo	Japan

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Other trials for the same condition

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02) Active, not recruiting

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06735742 on ClinicalTrials.gov ↗ ← All trials in Japan