Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation

NCT06405295 | Enrolling By Invitation

• 1 other identifier: NCC3896
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Carcinoma; BRCA Mutation; Adjuvant Drug Therapy

Outcome Measures

Primary Outcomes (1)

• iDFS%

  3 years

Secondary Outcomes (2)

• DRFS%

  3 years

• OS%

  3 years

Study Arms (3)

Capecitabine

Other: no intervention

Olaparib

Other: no intervention

Capecitabine and Olaparib

Other: no intervention

Interventions

no intervention OTHER

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

Capecitabine; Capecitabine and Olaparib; Olaparib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Early-stage triple-negative breast cancer with BRCA1/2 mutations treated at multiple hospitals in China with postoperative sequential treatment with capecitabine or olaparib or a combination of both drugs

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

BRCA gene testing

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Peng Yuan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 8, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 14, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)