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

Phase 2

• Conditions: Health Condition 1: C50- Malignant neoplasm of breastHealth Condition 2: C50- Malignant neoplasm of breast

• Registration Number: CTRI/2019/09/021060
• Lead Sponsor: Intramural fund of JIPMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <= 1.5 x upper limit of normal (ULN)

e. AST and ALT <= 3 x ULN

f. Alkaline phosphatase <= 5 x ULN

g. Creatinine <= 1.5 x ULN or estimated creatinine clearance >60ml/min/1.72m2.

Exclusion Criteria

1.Prior use of bisphosphonates for same or other indications

2.Symptomatic or biochemical hypocalcemia (Ca <7.4 with correction to albumn levels)

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological complete response rate of 42 percentTimepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
Disease free survival <br/ ><br>Overall survivalTimepoint: 2 years