Neo Adjuvant Chemotherapy in Triple Negative Breast Cancer

A Randomized Controlled Trial of Neoadjuvant Weekly Paclitaxel versus Weekly Paclitaxel Plus Weekly Carboplatin In Women with Triple Negative Breast Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/07/002802

Enrollment

720

Registered

2012-07-16

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Locally advanced or Large Operable Breast cancer patients with Triple Negative hormone receptor status. Health Condition 2: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Taxane Based Chemotherapy followed by Anthracycline Chemotherapy: The participant will receive Taxane Based Chemotherapy followed by Anthracycline Chemotherapy prior to surgery. Contro

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18-70 years 2.All women patients with triple negative hormone status planned for neoadjuvant chemotherapy 3.Patients with adequate baseline marrow function defined as ANC > 1500/mm3 and Platelet count > 1, 00,000/mm3. 4.Patients with acceptable liver function tests (normal bilirubin and AST/ALT 5.Patients willing to provide informed consent 6.Patients fit for chemotherapy

Exclusion criteria

Exclusion criteria: 1. Prior excision biopsy 2. Metastatic breast cancer 3. Women with inflammatory breast cancer 4. Poor cardiac function at baseline with LVEF 5. Patients with a prior history of a malignancy 6. Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
To see the effect of addition of platinum based chemotherapy on disease free and overall survival and response rates in triple negative breast cancer.Timepoint: 5 years after completion of accrual	—

Secondary

Measure	Time frame
Not AnyTimepoint: Not Any	—

Countries

India

Contacts

Public ContactDr Rajendra A Badwe

Tata memorial Centre

badwera@gmail.com022-24168601

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026