Breast CarcinomaNCT06405295
Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
An observational study of Breast Carcinoma and BRCA Mutation, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Carcinoma, BRCA Mutation, Adjuvant Drug Therapy
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to 1 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: A Multicentre Prospective Cohort Study: 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.
- Conditions
- Breast Carcinoma, BRCA Mutation, Adjuvant Drug Therapy
- Being tested
- no intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Not described Receives: Other: no intervention | |
| Olaparib | Not described Receives: Other: no intervention | |
| Capecitabine and Olaparib | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
iDFS%
Measured: 3 years
Secondary outcomes (2)
DRFS%
Measured: 3 years
OS%
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start6 May 2024
- Primary completion1 Mar 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PENG YUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Peng Yuan, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405295
- Sponsor's protocol ID
- NCC3896
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Cohort Study: Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
- ClinicalTrials.gov ID
- NCT06405295
- Acronym / sponsor ID
- NCC3896
- Conditions
- Breast Carcinoma, BRCA Mutation, Adjuvant Drug Therapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | – | Other: no intervention |
| Olaparib | – | Other: no intervention |
| Capecitabine and Olaparib | – | Other: no intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionObservation of the prognosis of patients with different standard treatment protocols in the clinic without intervention | Other | Capecitabine, Capecitabine and Olaparib, Olaparib |
Primary outcome
iDFS%
Time frame: 3 years
2 secondary outcomes
DRFS%
Time frame: 3 years
OS%
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peng Yuan principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and BRCA Mutation, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iDFS% (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.