Effect of addition of zoledronic acid to chemotherapy in improving the response of tumor before surgery, in women with breast cancer (triple negative subtype)

Effect of neoadjuvant treatment with zoledronic acid and chemotherapy in women with locally advanced triple negative breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/09/021060

Enrollment

107

Registered

2019-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C50- Malignant neoplasm of breast

Interventions

Intervention1: Zoledronic acid: Addition of Zoledronic acid to standard of care neoadjuvant chemotherapy Inj. Zoledronic acid 4mg in 100ml saline given intravenously over 30 min - every 21 days Contro

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven invasive carcinoma of breast 2. Locally advanced disease for neoadjuvant chemotherapy as per tumor clinic discussion. 3. Triple negative subtype i.e., Hormone negative (ER and PR score 0, HER2-negative (HER2 0 or 1+ on immunohistochemistry, or 2+ on immunohistochemistry and negative on fluorescence in situ hybridization-FISH). 4. Women of age 18- 70 5. Eastern Cooperative Oncology Group performance status of 0â??1 6. Left ventricular ejection fraction (LVEF) at least 50% by echocardiography 7. Laboratory results within 3 weeks prior to starting treatment a. Absolute neutrophil count >= 1,500/mm3 b. Platelet count >= 100,000/mm3 c. Hemoglobin >= 8 g/dl (no blood transfusion within the previous 2 weeks) d. Bilirubin e. AST and ALT f. Alkaline phosphatase g. Creatinine 60ml/min/1.72m2.

Exclusion criteria

Exclusion criteria: 1. Prior use of bisphosphonates for same or other indications 2. Symptomatic or biochemical hypocalcemia (Ca 3. Atrial fibrillation on ECG 4. Poor dental hygiene or lack of dental fitness (as ascertained by dental surgeonâ??s evaluation pretreatment) 5. Women who are pregnant or breastfeeding 6. Patients who are enrolled into or participating in any other clinical trial in past 3 months.

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate of 42 percentTimepoint: 6 months	—

Secondary

Measure	Time frame
Disease free survival Overall survivalTimepoint: 2 years	—

Countries

India

Contacts

Public ContactBiswajit Dubashi

Jawaharlal institute of postgraduate medical education and research

drbiswajitdm@gmail.com8056338405

Outcome results

None listed

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