Omitting the extra tumor‑bed boost after breast‑conserving surgery for patients who achieve a complete response to neoadjuvant chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single‑arm, phase II study enrolling patients with invasive breast cancer who achieve a pathologic complete response (ypT0) after guideline‑based neoadjuvant chemotherapy and breast‑conserving surgery. Enrolled patients will not receive additional dose escalation (a tumor‑bed boost) to the surgical site and will be followed for local‑regional recurrence, survival outcomes, and treatment‑related toxicity. The trial aims to identify the subgroup of patients for whom the boost can be safely omitted and to inform more precise adjuvant radiotherapy planning. It is described as the first prospective single‑arm effort focused specifically on omission of tumor‑bed boost in the pCR population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

(1) Voluntary participation, good compliance, able to cooperate with the trial observation, and having signed a written informed consent form; (2) Confirmed as invasive cancer through pathological tissue examination, and received baseline breast MR or PET/MR examination before neoadjuvant therapy; (3) Received the standard neoadjuvant treatment plan recommended by the guidelines based on molecular typing; (4) Single lesion, initially diagnosed as cT1-3N0-3a; (5) Underwent breast-conserving surgery, with negative surgical margins and a margin distance of ≥1mm, and achieved pCR of the primary breast lesion after NAC (ypT0); (6) Age 30-75 years, ECOG score 0-1; (7) Met the basic requirements for adjuvant radiotherapy, including basically normal peripheral blood count, no significant abnormalities in heart, liver, and kidney functions, and basically normal electrocardiogram; (8) Had no previous chest radiotherapy.

Exclusion Criteria:

(1) Pregnant women, lactating women, or women with reproductive capacity but without contraceptive measures in place; (2) Known to carry mutated susceptibility genes for breast cancer (including BRCA-1 and BRCA-2); (3) Diagnosed with cT4, N3b-c, bilateral breast cancer, with multiple primary lesions, multicentricity or non-bulky enhancement at the primary site; (4) Not receiving the standard neoadjuvant treatment regimen recommended by guidelines, or the primary breast lesion did not achieve pCR (including ypTis) after NAC; (5) Suffering from other malignant tumors or participating in other clinical trials simultaneously; (6) Unable to start radiotherapy within 8 weeks after breast cancer surgery; (7) Diagnosed with distant metastasis through initial imaging or pathology; (8) Previous history of breast cancer, history of radiotherapy in the neck, chest or ipsilateral axilla; (9) Severe non-tumor-related medical comorbidities affecting the implementation of radiotherapy; (10) Suffering from uncontrollable neurological, mental disorders or mental impairments, with poor compliance and inability to cooperate and describe treatment responses.

Where it's running

• The First Affiliated with Nanjing Medical University (Jiangsu Province People's Hospital)
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Xinchen Sun, Doctor — The First Affiliated with Nanjing Medical University (Jiangsu Province People's Hospital)
• Study coordinator: Xinchen Sun, Doctor
• Email: 13770662828@163.com
• Phone: 13770662828

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.