Comparing neoadjuvant and adjuvant radiotherapy for breast cancer

Neoadjuvant Radiotherapy Versus Adjuvant Radiotherapy for Breast Cancer: A Phase II Exploratory Randomized Controlled Clinical Study

This study is testing whether giving radiation therapy before or after surgery helps people with breast cancer do better and feel less side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Changhai Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06313073 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effects of neoadjuvant radiotherapy versus adjuvant radiotherapy in patients diagnosed with breast cancer. Participants will be randomly assigned to one of two groups: those receiving neoadjuvant radiotherapy before surgery and those receiving adjuvant radiotherapy after surgery. The study will evaluate the clinical effects based on postoperative specimens and assess both acute and late toxicity associated with preoperative radiotherapy. The goal is to determine which approach may offer better outcomes for patients.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 18 to 70 with invasive breast cancer requiring neoadjuvant therapy.

Not a fit: Patients with non-invasive breast cancer or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment strategies for breast cancer, potentially improving patient outcomes.

How similar studies have performed: Other studies have explored neoadjuvant versus adjuvant therapies in breast cancer, indicating potential benefits, but this specific approach may offer novel insights.

Eligibility criteria

Inclusion Criteria:

* Female;
* Age range from 18 to 70 years old;
* The pathological diagnosis is invasive cancer, and immunohistochemical examination has been performed to confirm the status of ER, PR, HER2, Ki67, etc;
* Clarify the BRCA gene mutation status;
* Patients who have a baseline stage of T1-3N0-3M0 and meet one of the following conditions and require neoadjuvant therapy: ① mass\>5cm; ② Axillary lymph node metastasis; ③ HER-2 positive; ④ Three Yin type; ⑤ Those who have a desire to preserve breast, but have a large ratio of tumor size to breast volume, making it difficult to preserve breast;
* Baseline estimation requires adjuvant radiotherapy, which meets one of the following conditions: ① performing breast conserving surgery; ② T3 or N positive patients after mastectomy and axillary dissection; ③ After mastectomy, sentinel lymph nodes were positive and axillary dissection was not performed;
* KPS score ≥ 80;
* The tumor must be visible in CT scan;
* Patients must undergo magnetic resonance imaging to help determine the contour of the tumor and exclude other lesions. If other lesions are found, biopsy must be performed on these lesions and the result is negative before continuing treatment;
* No history of serious internal medicine diseases or other serious comorbidities, such as a history of mental illness, allergies, etc;
* Sign an informed consent form.

Exclusion Criteria:

* Clinical or pathological stage T4 or M1 breast cancer;
* Received preoperative neoadjuvant therapy;
* Pathological confirmation shows that there is no invasive cancer component in DCIS;
* Double breast cancer or previous contralateral breast cancer;
* Imaging examination suggests suspicious malignant lesions in the ipsilateral or contralateral breast, which have not been pathologically confirmed to be benign;
* KPS score ≤ 70;
* There is active infection currently;
* Concomitant with severe heart, liver, kidney, hematopoietic and neurological diseases, psychiatric patients, or estimated survival time\<6 months;
* History of malignant tumors in other areas, excluding curable non melanoma skin cancer and cervical cancer in situ;
* History of radiation therapy at the site of previous radiation therapy;
* Pregnancy and lactation period;
* Those with poor compliance or life-threatening conditions who cannot complete treatment.

Where this trial is running

Shanghai, Shanghai

• Changhai hospital — Shanghai, Shanghai, China (Recruiting)

Conditions Neoadjuvant Radiotherapy; Breast Cancer; neoadjuvant radiotherapy; breast cancer