BRCA1-associated DNA Repair Dysfunction in Patients With Early Triple Negative Breast Cancer Treated With Neoadjuvant Platinum-based Chemotherapy

NCT01672671 | Completed Phase 2

• 1 other identifier: TNNP 001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess efficacy of platinum-based neoadjuvant chemotherapy in correlation with BRCA1-associated DNA repair dysfunction in patients with early triple negative breast cancer.

Conditions

Early Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The pathological complete response rate to neoadjuvant platinum-based chemotherapy

  Pathologic treatment response will be assessed in correlation with BRCA1-associated DNA repair dysfunction signature.

  after 8 weeks of neoadjuvant chemotherapy

Secondary Outcomes (2)

• Disease-free survival

  3 years

• Clinical responses to neadjuvant chemotherapy

  after 8 weeks of neoadjuvant chemotherapy

Other Outcomes (1)

• Number of patients with 3/4 Grade CTC adverse events to assess toxicity and tolerability of the chemotherapy regimen

  after 8 weeks of neadjuvant chemotherapy

Study Arms (1)

Neoadjuvant platinum-based chemotherapy

EXPERIMENTAL

Doxorubicin, Paclitaxel, Cisplatin

Drug: Doxorubicin, Paclitaxel, Cisplatin

Interventions

Doxorubicin, Paclitaxel, Cisplatin DRUG

Doxorubicin 25 mg/m2, IV weekly. Number of Cycles: 8 Paclitaxel 100 mg/m2, IV weekly. Number of Cycles: 8. Cisplatin 30 mg/m2, IV weekly. Number of Cycles: 8.

Neoadjuvant platinum-based chemotherapy

Eligibility Criteria

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

You may qualify if:

• Female patients, age ≥18 years≤75;
• Histologically confirmed invasive ER-, PR-, and HER2-negative (triple- negative) adenocarcinoma of the breast;
• Clinical stage T1-2, N0-1, M0.

You may not qualify if:

• Previous treatment for this breast cancer
• 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
• Pregnancy or breast-feeding

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead

Study Sites (1)

Russian Cancer Research Center named after N.N.Blokhin RAMS

Moscow, 115478, Russia

Location

Related Links

• Breast Cancer, Neoadjuvant Chemotherapy
• Doxorubicin, Paclitaxel, Cisplatin

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Doxorubicin; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate of Department of Clinical Pharmacology and Chemotherapy

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 27, 2012
• Study Start: August 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

RU (1)