Efficacy of Preoperative Radiotherapy for Non-responder Patients After Neoadjuvant Chemotherapy

NCT05274594 | Completed

• 1 other identifier: IstanbulBreast-22_01
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant chemotherapy (NACT) is widely used for locally advanced breast cancer cases. As the key factor is to achieve pathologic complete response (pCR), several physicians tried administering radiotherapy before surgery to increase response rates. In this single center observational cohort study, we aim to present the initial results as complete response rates and complication rates of additional neoadjuvant radiotherapy (NART) after NACT.

Conditions

Breast Neoplasms; Radiotherapy; Complications; Survivorship; Breast Cancer

Keywords

breast neoplasm; radiotherapy; neoadjuvant therapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Complete response rate following neoadjuvant radiotherapy

  Additional complete response effect of neoadjuvant radiotherapy for non-clinical complete responder patients following neoadjuvant chemotherapy.

  Up to 4 weeks after definitive surgery

Secondary Outcomes (1)

• Radiotherapy toxicity

  During the first Four weeks after the last dose of radiotherapy

Interventions

Radiotherapy RADIATION

Patients who are candidate for radiotherapy and received neoadjuvant chemotherapy for breast cancer were evaluated after neoadjuvant chemotherapy. Cases that do not have clinical response received radiotherapy before surgery in order to increase complete response.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients admitted to Istanbul Faculty of Medicine Breast Unit

You may qualify if:

• American Joint Committee on Cancer (AJCC) clinical T1-3
• Biopsy proven N+
• Non-metastatic (M0)
• Patients who are planned to receive adjuvant radiotherapy at initial evaluation
• Patients who are candidate for neoadjuvant chemotherapy
• Patients who did not achieved clinical complete response after neoadjuvant chemotherapy

You may not qualify if:

• AJCC clinical T4
• AJCC Clinical N-
• AJCC Clinical M1
• Patients who achieved clinical complete response after neoadjuvant chemotherapy
• Patients who did not consent to have neoadjuvant radiotherapy

Sponsors & Collaborators

• Istanbul Breast Society: lead

Study Sites (1)

Istanbul Breast Society

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (2)

• Ozkurt E, Sakai T, Wong SM, Tukenmez M, Golshan M. Survival Outcomes for Patients With Clinical Complete Response After Neoadjuvant Chemotherapy: Is Omitting Surgery an Option? Ann Surg Oncol. 2019 Oct;26(10):3260-3268. doi: 10.1245/s10434-019-07534-1. Epub 2019 Jul 24.

  PMID: 31342356 BACKGROUND

• Bollet MA, Belin L, Reyal F, Campana F, Dendale R, Kirova YM, Thibault F, Dieras V, Sigal-Zafrani B, Fourquet A. Preoperative radio-chemotherapy in early breast cancer patients: long-term results of a phase II trial. Radiother Oncol. 2012 Jan;102(1):82-8. doi: 10.1016/j.radonc.2011.08.017. Epub 2011 Sep 8.

  PMID: 21907436 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mahmut Müslümanoğlu, Prof. Dr.

  MD,FEBS,FACS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: March 10, 2022
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)