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

Phase 2

Completed

Brief Summary: This is a prospective, interventional, Phase 2 Pilot study to demonstrate feasibility and safety of concurrent CTRT in 60 patients of Ca Breast receiving adjuvant treatment at TMH and ACTREC. The primary outcome evaluates dose limiting toxicity and the secondary endpoints include late toxicity, quality of life and disease related outcome till 24 months.

Recruitment & Eligibility

Inclusion Criteria

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

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.
Patients with prior irradiation of breast/mediastinum/neck 10.

Primary Outcome Measures

Name	Time	Method
To demonstrate the feasibility and safety of concurrent CTRT regimen in adjuvant treatment of breast cancer.	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)

Locations (2): Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
🇮🇳
Raigarh, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
🇮🇳Raigarh, MAHARASHTRA, India
Dr Tabassum Wadasadawala
Principal investigator
02227405079
twadasadawala@actrec.gov.in