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NCT Number: NCT06735742

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Japan

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of adverse drug reactions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

TALZENNA Capsules Special Investigation - Investigation on BRCA Mutation-Positive and HER2-Negative Unresectable or Recurrent Breast Cancer With a History of Cancer Chemotherapy -

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 16, 2024
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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