Clinical trial NCT06926543: Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy
Official title: Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Invasive Breast Cancer
Stage III Breast Cancer
Stage IIB Breast Cancer
Keywords: Invasive breast cancer
Chemoradiation
Sequential
Concurrent
adjuvant therapy
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 858
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical research aims to determine if concurrent chemotherapy and radiation therapy is more effective than sequential chemotherapy and radiation therapy for patients with stage IIB-III breast cancer. It seeks to answer the following key questions:

1. When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival?
2. What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)?
3. What are each treatment approach's financial costs?

Researchers will compare the following to groups:

Arm A: Participants in the sequential treatment group will first undergo chemotherapy and then radiation.

and Arm B: Participants in the concurrent treatment group will undergo radiation therapy while undergoing chemotherapy.

Participants are going to:

1. Get the usual chemotherapy (taxanes and/or anthracyclines).
2. Receive radiation therapy for three to four weeks.
3. Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.


Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed invasive breast cancer
2. Stage IIB-III invasive breast cancer (AJCC 8th edition)
3. Patients planned for adjuvant chemotherapy and adjuvant radiotherapy
4. Patients fit to receive adjuvant chemotherapy and radiotherapy
5. Age \> 18 years

Exclusion Criteria:

1. Hypersensitivity to taxanes
2. Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting)
3. Unable or unwilling for regular follow up
4. Bilateral tumour needed RT to both sides
5. Patients planned for RT to oligometastatic sites
6. Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs (Exceeding the protocol specific mandatory dose constraints).
7. Pregnant patient

Primary outcomes:
measure: Study the 3-year Disease Free Survival.
timeFrame: From enrollment to 3 years after treatment at six months intervals.
Secondary outcomes:
measure: Impact of concurrent regimen on patient's Quality of life using the EORTC QLQ 30 and BR 23 and EQ5D5L questionnaire.
timeFrame: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
measure: Subjective and objective assessment of cosmesis in breast-conserving surgery patients, utilizing the Harvard scale and the BCCT core photographic evaluation, respectively.
timeFrame: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
measure: The difference in direct and indirect cost of treatment in the two arms will be assessed using the FACT-COST.
timeFrame: From enrollment at start of adjuvant chemotherapy, pre-radiotherapy and at post radiotherapy treatment.
measure: To assess the rate of lymphedema in the two arms of the trial using subjective and objective methods
timeFrame: From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 years
measure: Overall survival (OS)outcome assessment in the two arms.
timeFrame: From enrollment to 5 years after treatment at 6 months intervals
measure: Breast Cancer Specific Survival (BCSS) will be assessed with regular follow-ups.
timeFrame: From enrollment to 5 years after treatment at 6 months intervals
Other outcomes:
Locations:
city: Vishkhapatnam
country: India
facility: Homi Bhabha Cancer Hospital & Research Centre
state: Andhra Pradesh
city: Mumbai
country: India
facility: Tata Memorial Centre
state: Maharasthra
city: New Chandigarh
country: India
facility: Homi Bhabha Cancer Hospital and Research Centre
state: Punjab
city: Sangrur
country: India
facility: Homi Bhabha Cancer Hospital, Sangrur
state: Punjab
city: Varanasi
country: India
facility: Mahamana Pandit Madan Mohan Malviya Cancer Centre
state: Uttar Pradesh
Study officials:
References:
citation: Wadasadawala T, Anup A, Carlton J, Sarin R, Gupta S, Parmar V, Pathak R, Ghosh J, Bajpai J, Gulia S, Krishnamurthy R. CONcurrent ChEmotherapy and RadioTherapy in adjuvant treatment of breast cancer (CONCERT): a phase 2 study. Ecancermedicalscience. 2023 Feb 23;17:1510. doi: 10.3332/ecancer.2023.1510. eCollection 2023.