Assess the efficacy of endocrine therapy preoperatively in patients who are hormone receptor positive

Fall in Ki67 Index after 2 Weeks or 4 Weeks of Preoperative Endocrine Therapy as a Means to Assess the Risk of Recurrence: A Randomized Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039736

Enrollment

200

Registered

2022-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Letrozole 2.5 mg tablet : Letrozole 2.5 mg tablet, administered once daily for two weeks before surgery (in postmenopausal women) Intervention2: Tamoxifen 20mg tablet: Tamoxifen 20mg

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18 years and above. 2. Hormone receptor positive ( >1% estrogen receptor) invasive breast cancer 3. Human epidermal growth factor receptor 2 negative (HER2-ve) breast cancers 4. ECOG performance status 0-1 5. Those who have not received chemotherapy or endocrine therapy for breast cancer in the last 5 years. 6. Those who have paraffin fixed core needle tissue block or biopsy punch available for analysis for proliferative markers 7. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women 2. Prior malignancy 3. Evidence of metastatic disease 4. Locally advanced/ inoperable breast cancer 5. High nodal burden 6. Contraindication to endocrine therapy 7. Inhibit or unwillingness to swallow tablets 8. Patients who are not willing to participate in the study.

Design outcomes

Primary

Measure	Time frame
fall in Ki-67 in Hormone receptor positive HER2 negative breast cancer patients receiving preoperative endocrine therapyTimepoint: 4 weeks	—

Secondary

Measure	Time frame
compare the difference in Standardized Uptake Value (SUV) in node positive, HR positive HER2 negative breast cancer patients receiving preoperative endocrine therapy for different time interval (two weeks and four weeks).Timepoint: 4 weeks;correlation between the fall in Ki-67 index and CanAssist breast (CAB) score in HR positive HER2 negative breast cancer patients receiving preoperative endocrine therapyTimepoint: 4 weeks;fall in Ki67 index in patients receiving preoperative endocrine therapy for different time interval (two weeks and four weeks).Timepoint: 4 weeks;Safety and Tolerability of the endocrine therapyTimepoint: 4 weeks	—

Measure

Time frame

compare the difference in Standardized Uptake Value (SUV) in node positive, HR positive HER2 negative breast cancer patients receiving preoperative endocrine therapy for different time interval (two weeks and four weeks).Timepoint: 4 weeks;correlation between the fall in Ki-67 index and CanAssist breast (CAB) score in HR positive HER2 negative breast cancer patients receiving preoperative endocrine therapyTimepoint: 4 weeks;fall in Ki67 index in patients receiving preoperative endocrine therapy for different time interval (two weeks and four weeks).Timepoint: 4 weeks;Safety and Tolerability of the endocrine therapyTimepoint: 4 weeks

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Countries

India

Contacts

Public ContactDhanya Mary Louis

Amrita Institute of Medical Sciences

dkvijaykumar@gmail.com9744870684

Outcome results

None listed

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