A Study Comparing Two Chemotherapy Schedules Before Surgery in Patients with Triple-Negative Breast Cancer

A Phase II Randomized Controlled Trial Comparing Alternating Versus Sequential Dose-Dense AC and Taxane Chemotherapy in the Neoadjuvant Treatment of Triple-Negative Breast Cancer - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092935

Enrollment

Registered

2025-08-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Alternating AC T Schedule: alternating cycles of: o EC: Epirubicin 90mg/m + Cyclophosphamide 600 mg/m on Day 1 o T: Paclitaxel 175 mg/m on Day 1 Administered every 2 weeks 8 tota

Eligibility

Inclusion criteria

Inclusion criteria: Histologically confirmed triple negative breast cancer (ER negative PR negative HER2 negative) and Stage I to III. Planned for neoadjuvant chemotherapy with AC and not affordable for immunotherapy. ECOG performance status 0 to 1. Adequate bone marrow, renal, hepatic and cardiac function. Written informed consent provided.

Exclusion criteria

Exclusion criteria: Prior chemotherapy or radiotherapy. Pre existing neuropathy assessed by nerve conduction study. Uncontrolled diabetes (HbA1c more than 8) Active or uncontrolled infection or significant comorbidity interfering with protocol compliance. Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
1.Change in global quality of life (QoL) from baseline to the end of chemotherapy, measured using the EORTC QLQ-C30 questionnaire.Timepoint: 1.Change in global quality of life (QoL) from baseline to the end of chemotherapy, measured using the EORTC QLQ-C30 questionnaire.	—

Secondary

Measure	Time frame
Incidence & severity of peripheral neuropathy, assessed usingTimepoint: Patient-reported outcomes via the CIPN20 questionnaire estimated at baseline, after 6 weeks, & after 14 weeks. Objective evaluation through nerve conduction studies (NCS) at baseline & at the end of chemotherapy after 14 weeks.;Overall toxicity profile, assessed clinically at the end of each chemotherapy cycle and graded using CTCAE v5.0.Timepoint: ;Treatment completion rates, defined as the proportion of patients completing all 8 planned chemotherapy cycles without dose reductions or delays.Timepoint: ;Pathological complete response (pCR) rates, defined as the absence of invasive cancer in the breast and axillary nodes (ypT0/is, ypN0) at the time of definitive surgery, compared between the two arms.Timepoint:	—

Measure

Time frame

Incidence & severity of peripheral neuropathy, assessed usingTimepoint: Patient-reported outcomes via the CIPN20 questionnaire estimated at baseline, after 6 weeks, & after 14 weeks. Objective evaluation through nerve conduction studies (NCS) at baseline & at the end of chemotherapy after 14 weeks.;Overall toxicity profile, assessed clinically at the end of each chemotherapy cycle and graded using CTCAE v5.0.Timepoint: ;Treatment completion rates, defined as the proportion of patients completing all 8 planned chemotherapy cycles without dose reductions or delays.Timepoint: ;Pathological complete response (pCR) rates, defined as the absence of invasive cancer in the breast and axillary nodes (ypT0/is, ypN0) at the time of definitive surgery, compared between the two arms.Timepoint:

—

Countries

India

Contacts

Public ContactDr Atul Batra

All India Institute of Medical Science, New Delhi

batraatul85@gmail.com9013078407

Outcome results

None listed

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