Neoadjuvant chemotherapy followed by radiation therapy for breast cancer patients
Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer
This study tests if giving radiation therapy alone after chemotherapy can help older breast cancer patients who have no signs of cancer avoid surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | Female |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT03213925 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of administering radiation therapy alone after neoadjuvant chemotherapy in patients with breast cancer who have achieved a complete response. The study aims to determine if surgical intervention can be avoided in this subgroup of patients, potentially streamlining treatment and reducing the need for invasive procedures. Participants will receive radiation therapy without undergoing surgery, allowing researchers to assess the outcomes of this approach. The trial focuses on patients aged 40 and older with specific clinical stages of breast cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 40 and older with pathologically confirmed unicentric invasive breast cancer who have responded completely to neoadjuvant chemotherapy.
Not a fit: Patients with prior cancer diagnoses (except certain in situ tumors), those who are pregnant, or individuals who have previously received radiation therapy in the thoracic region may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for surgery in certain breast cancer patients, leading to less invasive treatment options.
How similar studies have performed: While the approach of avoiding surgery in favor of radiation therapy is innovative, similar studies have shown promise in reducing surgical interventions for certain cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 40 years or older * Pathologically confirmed unicentric invasive breast cancer * Clinical stage T1-3 / N0 or N2 / M0 * Clinical conditions to receive neoadjuvant chemotherapy Exclusion Criteria: * Prior diagnosis of cancer (exception: in situ cervical tumor and non-melanoma skin) * Patient is known to be pregnant * Prior history of radiation therapy in the thoracic region * Impossibility to perform magnetic resonance imaging
Where this trial is running
São Paulo
- Department of Radiology and Oncology of University of São Paulo - Radiation Oncology Unit, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina da Universidade de São Paulo — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Gustavo N Marta, PhD
- Email: gustavo.marta@hc.fm.usp.br
- Phone: +55 11 38934538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.