Last reviewed · How we verify
NCT06635980
Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer
Phase 2 trial testing Biopsy of Breast in Anatomic Stage I Breast Cancer AJCC v8 in 120 participants. Currently enrolling.
21 October 2031
Quick facts
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 14 May 2025 |
| Primary completion | 21 October 2031 |
| Estimated completion | 21 October 2034 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Biopsy of Breast
- Biospecimen Collection — full drug profile →
- Breast Surgery
- Chemotherapy (chemotherapy) — full drug profile →
- Computed Tomography
- Contrast Enhanced Digital Mammography
- Hypofractionated Radiation Therapy — full drug profile →
- Magnetic Resonance Imaging
- Positron Emission Tomography
- Survey Administration
- Tissue Collection
- Ultrasound Imaging
Conditions studied
- Anatomic Stage I Breast Cancer AJCC v8 — all drugs for Anatomic Stage I Breast Cancer AJCC v8 →
- Anatomic Stage II Breast Cancer AJCC v8 — all drugs for Anatomic Stage II Breast Cancer AJCC v8 →
- Anatomic Stage III Breast Cancer AJCC v8 — all drugs for Anatomic Stage III Breast Cancer AJCC v8 →
- Breast Carcinoma — all drugs for Breast Carcinoma →
Sponsor
Mayo Clinic
Who can join
18 and older, female only, with Anatomic Stage I Breast Cancer AJCC v8 or Anatomic Stage II Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies how well hypofractionated radiotherapy before (preoperative) or after (postoperative) breast surgery works in treating patients with different types of non-metastatic (has not spread from original tumor site) breast cancer and to determine the outcomes and side effects of this treatment. Radiation therapy is considered an integral part of breast conserving therapy. Hypofractionated radiation therapy is a radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less than once a day. This has been shown to be an effective treatment for breast cancer while reducing treatment time and decreasing side effects. Preoperative radiotherapy alone or concurrently with chemotherapy has also been tested with excellent results and with minimal toxicity. Preoperative radiation of the intact tumor with a hypofractionated regimen can potentially decrease toxicity by allowing the delivery of treatment to intact breast tissue. The potential advantages of preoperative radiation therapy include the delivery of radiation in the intact breast when radiation can be more effective as more oxygen can be available in the tissue. Furthermore, complications and cosmetic results are expected to be lower in pre-operative radiotherapy before surgery, as there have been no changes in blood supply to the breast. This lends to the possibility of using lower doses of radiotherapy to patients, and potentially better cancer associated clinical outcomes for our breast cancer patients. Undergoing hypofractionated radiation therapy before or after breast surgery may be safe and effective in treating patients with different types of non-metastatic breast cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06635980
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Biopsy of Breast
Trials testing the same drug.
- NCT06502691 — [18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Ca · Phase 1, PHASE2 · recruiting
- NCT06058650 — Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities · NA · recruiting
- NCT03128619 — Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Brea · Phase 1 · terminated
- NCT03188393 — Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery · Phase 2 · completed
- NCT03031561 — Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormal · NA · completed
Other recruiting trials for Anatomic Stage I Breast Cancer AJCC v8
Currently open trials in the same condition.
- NCT07443943 — A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive · Phase 2 · recruiting
- NCT07158021 — Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial · Phase 2 · recruiting
- NCT06324240 — Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Canc · Phase 1 · recruiting
- NCT07407920 — Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial · Phase 2 · active not recruiting
- NCT06876714 — ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathol · Phase 3 · recruiting
Other Mayo Clinic trials
Trials by the same sponsor.
- NCT07126548 — A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men · NA · not yet recruiting
- NCT07221656 — Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration · not yet recruiting
- NCT06891001 — The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, · NA · not yet recruiting
- NCT07169799 — Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE) · NA · recruiting
- NCT07086183 — Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06635980 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
- Last refreshed: 12 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06635980.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing