A pilot study of giving chemotherapy and radiotherapy concomitantly after breast cancer surgery

Phase 2

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

Registration Number: CTRI/2019/02/017411

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Pathologically confirmed invasive breast cancer

2. Stage II-III invasive breast cancer (AJCC 8th edition)

3. Patients planned for taxane-based adjuvant chemotherapy and adjuvant radiotherapy after curative-intent surgery irrespective of her2 status and receipt of anti-her2 therapy

4. Patients fit to receive taxane based chemotherapy

5. Age > 18 years

6. Willing to provide venous blood sample

7. Consent for photograhic assessment in case of breast conservation

Exclusion Criteria

1. Hypersensitivity to taxanes

2. Patients meriting extended field radiotherapy (to internal mammary nodes and/or axillary nodes)

3. Bilateral breast cancer meriting radiotherapy to both sides

4. Unable or unwilling to give written informed consent

5. Unable or unwilling for regular follow up

6. Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs

7. Patient undergone immediate whole breast reconstruction

8. Patients receiving dose dense regimens.

9. Patients with prior irradiation of breast/mediastinum/neck

10. Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the feasibility and safety of concurrent CTRT regimen in adjuvant treatment of breast cancer.Timepoint: Incidence of concurrent chemo-radiotherapy associated dose limiting toxicity will be assessed during as well as after treatment up to 3 months.

Secondary Outcome Measures

Name	Time	Method
To assess the compliance rate and incidence of severe toxicity; To study impact of concurrent regimen on patient Quality of life; To compare severe acute toxicity rates of the two schedules of taxanes: 3 weekly and weekly; Short term disease related outcomes of concurrent CTRT in terms of overall survival (OS), loco-regional failure-free survival (LRFFS), breast cancer specific survival (BCSS) <br/ ><br>Timepoint: Study the impact of concurrent CTRT on global Quality of life scores up to 2 years post treatment; Disease free survival at 3 years; Breast cancer specific survival at 3 years; Overall survival at 3 years <br/ ><br>