Breast conserving surgery with intraoperative radiotherapy for early breast cancer

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 observational study analyzes the local recurrence rate, incidence of incision complications, and aesthetic outcomes of intraoperative radiotherapy (IORT) combined with breast-conserving surgery in early breast cancer patients. A total of 620 patients are included, with some receiving IORT and others undergoing whole breast irradiation (WBI) based on their preferences. The study aims to evaluate the effectiveness of IORT compared to traditional WBI in terms of patient outcomes and satisfaction. The treatment regimens are tailored based on postoperative pathology and immunohistochemical reports.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥55 years old；
2. Cytology or histology confirmed invasive breast cancer or intraductal carcinoma in situ (DCIS) with a clinical stage of Tis-1N0M0；
3. Patients who are willing to preserve milk and intend to undergo breast-conserving surgery；
4. If invasive breast cancer is confirmed, the surgical margin negative ≥2mm should be met. If DCIS is confirmed, the surgical margin should be negative ≥3mm；
5. ER≥ 30% and PR≥ 1%, HER2 negative；
6. Voluntary participation in this study, signed informed consent, good compliance, cooperate with follow-up.

Exclusion Criteria:

1. Simultaneous diagnosis of bilateral or multifocal breast cancer；
2. Previous ipsilateral breast cancer and/or prior chest wall radiation therapy；
3. There are active connective tissue diseases such as scleroderma and systemic lupus erythematosus in the chest；
4. The investigators did not consider the patient suitable for participation in any other conditions of the study.

Where it's running

• The Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting

Study contacts

• Study coordinator: cuizhi GENG, archiater
• Email: gengcuizhi@hotmail.com
• Phone: 135 0321 6325

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• RGT-490 for adults with PIK3CA-mutated advanced solid tumors

  This trial will test RGT-490, an oral medicine, in adults whose advanced solid tumors carry a PIK3CA mutation and have progressed after prior therapy.

  Recruiting at 6 sites Phase 1 Regor Pharmaceuticals Inc. · Los Angeles, California and 5 other locations · NCT07524322

• Pre-surgery hormone therapy to lower positive margins in lobular breast cancer

  This Phase 2 trial tests whether giving endocrine (hormone) therapy before breast-conserving surgery can reduce the chance of cancer at the edges of the removed tissue in postmenopausal people with ER+/HER2- invasive lobular breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07483307

• Capivasertib plus endocrine therapy for HR+/HER2- advanced breast cancer after progression on endocrine treatment

  This trial will test whether adding capivasertib to standard endocrine therapy helps adults with HR+/HER2- advanced or metastatic breast cancer who progressed on prior endocrine treatment stay on treatment longer and maintain quality of life.

  Recruiting at 15 sites Phase 3 Women's Cancer Study Group GmbH · Anderlecht and 15 other locations · NCT07281833

• Elacestrant plus trastuzumab deruxtecan for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after CDK4/6 and endocrine therapy

  This trial tests whether combining elacestrant with trastuzumab deruxtecan helps people with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer that progressed after CDK4/6 inhibitor and endocrine treatment.

  Recruiting Phase 1/2 Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07198724

• RLY-2608 plus fulvestrant versus capivasertib plus fulvestrant for PIK3CA‑mutant HR+/HER2‑ advanced breast cancer

  This trial tests whether RLY-2608 combined with fulvestrant works better than capivasertib combined with fulvestrant for adults with HR+/HER2‑ advanced breast cancer that has a PIK3CA mutation and progressed after a CDK4/6 inhibitor.

  Recruiting at 254 sites Phase 3 Relay Therapeutics, Inc. · Gilbert, Arizona and 253 other locations · NCT06982521

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.