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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 November 2015 |
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Main ID: |
NCT01672671 |
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Date of registration:
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16/08/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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BRCA1-associated DNA Repair Dysfunction in Patients With Early Triple Negative Breast Cancer Treated With Neoadjuvant Platinum-based Chemotherapy
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Scientific title:
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Identification of BRCA1-associated DNA Repair Dysfunction in Patients With Early Triple Negative Breast Cancer Treated With Neoadjuvant Platinum-based Chemotherapy |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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41 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01672671 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Russian Federation
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Female patients, age =18 years=75;
2. Histologically confirmed invasive ER-, PR-, and HER2-negative (triple- negative)
adenocarcinoma of the breast;
3. Clinical stage T1-2, N0-1, M0.
Exclusion Criteria:
1. Previous treatment for this breast cancer
2. History of malignancy treated with curative intent within the previous 5 years with
the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid
cancer. Patients with previous invasive cancers (including breast cancer) are
eligible if the treatment was completed more than 5 years prior to initiating current
study treatment, and there is no evidence of recurrent disease
3. Pregnancy or breast-feeding
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Early Triple Negative Breast Cancer
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Intervention(s)
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Drug: Doxorubicin, Paclitaxel, Cisplatin
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Primary Outcome(s)
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The pathological complete response rate to neoadjuvant platinum-based chemotherapy
[Time Frame: after 8 weeks of neoadjuvant chemotherapy]
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Secondary Outcome(s)
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Clinical responses to neadjuvant chemotherapy
[Time Frame: after 8 weeks of neoadjuvant chemotherapy]
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Disease-free survival
[Time Frame: 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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