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NCT Number: NCT06926543

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

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.

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Key information

Conditions

Invasive Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stage IIB Breast Cancer Stage III Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Homi Bhabha Cancer Hospital & Research Centre, Vishkhapatnam, Andhra Pradesh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Chemoradiation

Drug

This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner

Primary outcomes

  1. Study the 3-year Disease Free Survival.

    Time frame: From enrollment to 3 years after treatment at six months intervals.

Secondary outcomes

  1. 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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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

    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.

  5. Overall survival (OS)outcome assessment in the two arms.

    Time frame: From enrollment to 5 years after treatment at 6 months intervals

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Tabassum Wadasadawala, MD, DNB Radiotherapy

CONTACT

[email protected]

(+91-22) 24177026 ext. 7026

Sponsors and collaborators

Lead sponsor

Dr. Tabassum Wadasadawala

Other

Registry information

Official study title

Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)

Acronym: CONCERT

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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