Low dose Capecitabine in Triple Negative Breast Cancer patients as maintenance in Indian Women

METRONOMIC CAPECITABINE FOR MAINTENANCE IN NON METASTATIC TRIPLE NEGATIVE BREAST CANCER [TNBC] AFTER STANDARD TREATMENT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054056

Enrollment

Registered

2023-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: C506- Malignant neoplasm of axillary tail of breast Health Condition 2: C501- Malignant neoplasm of central portion of breast Health Condition 3: C503- Malignant neoplasm of lower-innerquadrant of breast Health Condition 4: C505- Malignant neoplasm of lower-outerquadrant of breast Health Condition 5: C508- Malignant neoplasm of overlappingsites of breast Health Condition 6: C502- Malignant neoplasm of upper-innerquadrant of breast Health Condition 7: C504- Malignant neoplasm

Interventions

Intervention1: Tablet Capecitabine: Tablet Capecitabine - 650 mg/m2 Twice Daily with Tablet Pyridoxine 50 mg Twice daily - Per Oral for 12 months daily (for maintenance after standard treatment) Con

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 25 -75 yrs. 2. Karnofsky performance status more than 70 3. Completed planned standard therapy (Surgery, Chemotherapy- neoadjuvant/ adjuvant, Radiotherapy) 4. Proven to be non metastatic after standard treatment also by imaging with whole body PET-CT before starting tab. Capecitabine. 5. No other synchronous malignancy

Exclusion criteria

Exclusion criteria: 1. Age 75 yrs. 2. With history of treatment for Breast cancer or for any other Malignancy 3. Deranged liver and kidney functions 4. Deranged coagulation profile [bleeding time, clotting time, PT-INR] 5. Known hypersensitivity to capacitabine or 5-Flourouracil 6. Metastatic Disease at presentation or after completion of standard therapy

Design outcomes

Primary

Measure	Time frame
To assess the tolerability & toxicities of Metronomic capacitabine as maintenance therapy [post standard treatment] in non-metastatic TNBC patientsTimepoint: Tolerability and Toxicities assessed ever month for 12 months	—

Secondary

Measure	Time frame
To establish the Disease free survival of these patients at 2 yearsTimepoint: To establish the Disease free survival of these patients at 2 years	—

Countries

India

Contacts

Public ContactDr SVS Bala

Maharishi Markandeshwar Institute of Medical Sciences and Research Centre

balasvs109@gmail.com9176853611

Outcome results

None listed

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