Invasive Breast CancerPhase 3CONCERTNCT06926543
Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy
A Phase 3 study testing Chemoradiation in people with Invasive Breast Cancer and Stage III Breast Cancer, run by Dr. Tabassum Wadasadawala at 5 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Breast Cancer, Stage III Breast Cancer, Stage IIB Breast Cancer
- What is being tested?
- Chemoradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 858 participants
- Where
- 5 sitesIndia
- Study dates
- 14 May 2024to May 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed invasive breast cancer
- Stage IIB-III invasive breast cancer (AJCC 8th edition)
- Patients planned for adjuvant chemotherapy and adjuvant radiotherapy
- Patients fit to receive adjuvant chemotherapy and radiotherapy
- Age > 18 years
Who cannot join
- Hypersensitivity to taxanes
- Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting)
- Unable or unwilling for regular follow up
- Bilateral tumour needed RT to both sides
- Patients planned for RT to oligometastatic sites
- Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs (Exceeding the protocol specific mandatory dose constraints).
- Pregnant patient
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tabassum Wadasadawala, MD, DNB Radiotherapy contact
5 sites in 1 country
India5 sites, 5 recruiting
- Recruiting
Tata Memorial Centre
Mumbai, Maharasthra, 400012
Tabassum Wadasadawala, (+91-22) 24177026, drtabs.radonc@gmail.com
Tabassum Wadasadawala, MD, DNB (Radiotherapy)
- Not yet recruiting
Homi Bhabha Cancer Hospital and Research Centre
New Chandigarh, Punjab, 140901
Pragyat Thakur, +910160 281 0022, pragyat28rpgmc@gmail.com
Pragyat Thakur
- Not yet recruiting
Homi Bhabha Cancer Hospital, Sangrur
Sangrur, Punjab, 148001
Jayashree Deshmkh, +910167 224 1241, drjanvi299@gmail.com
Jayashree Deshmukh
- Not yet recruiting
Mahamana Pandit Madan Mohan Malviya Cancer Centre
Varanasi, Uttar Pradesh, 221005
Lincoln Pujari, +910542 691 7700, lincoln.puraji@gmail.com
Lincoln Pujari
- Not yet recruiting
Homi Bhabha Cancer Hospital & Research Centre
Vishkhapatnam, Andhra Pradesh, 530053
Rohit Vadgaonkar, +910167 224 1241, dr.ravad@gmail.com
Rohit Vadgaonkar
About this study
Official title: Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)
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:
- When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival?
- What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)?
- What are each treatment approach's financial costs?
Read more
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:
- Get the usual chemotherapy (taxanes and/or anthracyclines).
- Receive radiation therapy for three to four weeks.
- Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.
- Being tested
- Chemoradiation
- Keywords
- Invasive breast cancer, Chemoradiation, Sequential, Concurrent, adjuvant therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiationDrug
This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
ChemoradiationDrug
This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Standard Arm | Active comparator | Participants randomized to arm A arm will receive sequential chemotherapy and radiotherapy Receives: Drug: Chemoradiation |
| Arm B: Experimental arm | Experimental | Participants randomized to arm B will receive concurrent chemotherapy and radiotherapy Receives: Drug: Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the 3-year Disease Free Survival.
Measured: From enrollment to 3 years after treatment at six months intervals.
Secondary outcomes (6)
Impact of concurrent regimen on patient's Quality of life using the EORTC QLQ 30 and BR 23 and EQ5D5L questionnaire.
Measured: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
Subjective and objective assessment of cosmesis in breast-conserving surgery patients, utilizing the Harvard scale and the BCCT core photographic evaluation, respectively.
All patients who undergo breast conservation surgery will be eligible for this sub-study in which we intend to collect frontal breast photographs for objective assessment of breast cosmesis.
Measured: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
The difference in direct and indirect cost of treatment in the two arms will be assessed using the FACT-COST.
As patients in the intervention arm will complete their treatment at least 6-8 weeks before the patients in the standard arm, it will have huge impact on the expenditure that the patient bears for staying, food as well as transport to the hospital. Hence, we would like to collect data pertaining to patient's daily expenditure during their adjuvant treatment.
Measured: From enrollment at start of adjuvant chemotherapy, pre-radiotherapy and at post radiotherapy treatment.
To assess the rate of lymphedema in the two arms of the trial using subjective and objective methods
As the breast cancer treatment increases the risk of swelling in the upper limb, we would like to assess for the same. This will help us to diagnose lymphedema at an early stage and will be able to treat it more effectively.
Measured: From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 years
Overall survival (OS)outcome assessment in the two arms.
Measured: From enrollment to 5 years after treatment at 6 months intervals
Breast Cancer Specific Survival (BCSS) will be assessed with regular follow-ups.
Measured: From enrollment to 5 years after treatment at 6 months intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start14 May 2024
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 858 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Tabassum Wadasadawala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Tabassum Wadasadawala, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926543
- Sponsor's protocol ID
- 4131
- Other IDs
- CTRI/2023/06/054280
- Acronym
- CONCERT
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37113709
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)
- ClinicalTrials.gov ID
- NCT06926543
- Acronym / sponsor ID
- CONCERT / 4131
- Keywords
- Invasive breast cancer, Chemoradiation, Sequential, Concurrent, adjuvant therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 858 participants (estimated)
- Lead sponsor
- Dr. Tabassum WadasadawalaUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival?
- What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)?
- 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:
- Get the usual chemotherapy (taxanes and/or anthracyclines).
- Receive radiation therapy for three to four weeks.
- Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Standard Arm | Active comparator | Drug: ChemoradiationParticipants randomized to arm A arm will receive sequential chemotherapy and radiotherapy |
| Arm B: Experimental arm | Experimental | Drug: ChemoradiationParticipants randomized to arm B will receive concurrent chemotherapy and radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed invasive breast cancer
- Stage IIB-III invasive breast cancer (AJCC 8th edition)
- Patients planned for adjuvant chemotherapy and adjuvant radiotherapy
- Patients fit to receive adjuvant chemotherapy and radiotherapy
- Age > 18 years
Key exclusion criteria (7 listed)
- Hypersensitivity to taxanes
- Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting)
- Unable or unwilling for regular follow up
- Bilateral tumour needed RT to both sides
- Patients planned for RT to oligometastatic sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoradiationThis intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner | Drug | Arm A: Standard Arm |
| ChemoradiationThis intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner. | Drug | Arm B: Experimental arm |
Primary outcome
Study the 3-year Disease Free Survival.
Time frame: From enrollment to 3 years after treatment at six months intervals.
6 secondary outcomes
Impact of concurrent regimen on patient's Quality of life using the EORTC QLQ 30 and BR 23 and EQ5D5L questionnaire.
Time frame: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
Subjective and objective assessment of cosmesis in breast-conserving surgery patients, utilizing the Harvard scale and the BCCT core photographic evaluation, respectively.
Time frame: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
The difference in direct and indirect cost of treatment in the two arms will be assessed using the FACT-COST.
Time frame: From enrollment at start of adjuvant chemotherapy, pre-radiotherapy and at post radiotherapy treatment.
To assess the rate of lymphedema in the two arms of the trial using subjective and objective methods
Time frame: From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 years
Overall survival (OS)outcome assessment in the two arms.
Time frame: From enrollment to 5 years after treatment at 6 months intervals
Breast Cancer Specific Survival (BCSS) will be assessed with regular follow-ups.
Time frame: From enrollment to 5 years after treatment at 6 months intervals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 37113709Wadasadawala 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.
- A Pilot Study of CONcurrent ChEmotherapy and RadioTherapy in Adjuvant Treatment of Breast Cancer (CONCERT)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tabassum Wadasadawala, MD, DNB Radiotherapy contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chemoradiation in people with Invasive Breast Cancer and Stage III Breast Cancer, run by Dr. Tabassum Wadasadawala at 5 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tabassum Wadasadawala, MD, DNB Radiotherapy ((+91-22) 24177026 ext. 7026, drtabs.radonc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the 3-year Disease Free Survival. (time frame: From enrollment to 3 years after treatment at six months intervals.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06926543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.