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OpenTrials
Enrolling by Invitation

NCT Number: NCT06405295

Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation

Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.

Enrolling by Invitation

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ECOG score 0-1
  • TNBC
  • BRCA1/2 mutation
  • No distant metastases assessed by imaging after surgical treatment
  • Breast cancer that is non-pCR after neoadjuvant therapy, or postoperative pathology suggestive of ≥pT2, or ≥pN1
  • Have completed postoperative adjuvant chemotherapy and/or radiotherapy
  • No major organ dysfunction

Exclusion criteria

  • Patients who are unable to take oral medication, or who refuse this medication regimen
  • Already enrolled in another study, or less than or equal to 4 weeks from discontinuation of another medication
  • Presence of severe dysfunction of vital organs
  • Patients with other malignancies (with the exception of cured non-melanoma skin cancers, carcinoma in situ of the cervix and other tumours that have been cured for at least 5 years)
  • Acute infectious disease or active chronic infectious disease
  • History of uncontrolled epilepsy, central nervous system disease or mental disorder

Treatment and study plan

No intervention

Other

Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention

Primary outcomes

  1. iDFS%

    Time frame: 3 years

Secondary outcomes

  1. DRFS%

    Time frame: 3 years

  2. OS%

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

A Multicentre Prospective Cohort Study: Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
May 8, 2024
Registry last updated
Feb 14, 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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