NCT05856773 Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy
| NCT ID | NCT05856773 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Proton Collaborative Group |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2024-03-21 |
| Primary Completion | 2038-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 276 participants in total. It began in 2024-03-21 with a primary completion date of 2038-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.
Eligibility Criteria
Inclusion Criteria: * Patients with Stage I-III breast cancer who have undergone breast conserving surgery or mastectomy and have been recommended to receive postoperative radiation therapy to the breast or chest wall and regional draining lymph nodes (axilla levels I-III, SCV, IMN) * Histologically documented breast cancer (invasive mammary, ductal, medullary, tubular, metaplastic, mucinous, lobular, or ductal carcinoma in situ) for which treatment with radiation therapy to the breast/chest wall and comprehensive regional lymph nodes including the internal mammary chain is recommended * No clinical evidence or suspicion of distant metastatic disease * History and physical exam within 90 days prior to study registration * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Negative pregnancy test for women of child-bearing potential * Able to begin radiation treatment within 12 weeks of last surgery or last day of chemotherapy * Presence of breast implants, breast expanders, tissue flap, or other breast reconstruction are allowed * Bilateral breast cancer is allowed if at least one side will be treated with comprehensive nodal irradiation per protocol treatment and will be recorded as the laterality receiving comprehensive nodal irradiation. If both sides will be treated comprehensively, it will be documented as such Exclusion Criteria: * Presence of skin ulceration and / or ipsilateral satellite nodules and/or edema (including peau d'orange) (T4b or T4c disease) or diagnosis of inflammatory breast cancer (T4d disease) * Residual gross disease detected by imaging or clinical exam with the exception of \<2cm internal mammary lymph node or supraclavicular lymph node amenable to sequential boost * Prior history of radiation therapy overlapping with current target volume (including intraoperative brachytherapy, interstitial catheter brachytherapy, balloon brachytherapy, external beam radiation therapy) * Prior history of explant surgery or implant removal due to infection or wound healing issues without subsequent implant or flap reconstruction * Presence of double/dual port tissue expander * Clinical or radiographic evidence of distant metastatic disease * Pregnant or breast-feeding females * Non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up * History of connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum * Known BRCA 1 or BRCA 2 mutation * Presence of an active skin rash * Prior history of breast cancer * Prior invasive non-study malignancy unless disease free for ≥ 3 years. Non-melanoma skin cancer, well-differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.
Contact & Investigator
Isabelle Choi, MD
STUDY CHAIR
Proton Collaborative Group
Frequently Asked Questions
Who can join the NCT05856773 clinical trial?
This trial is open to female participants only, aged 19 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05856773 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 276 participants.
Is NCT05856773 currently recruiting?
Yes, NCT05856773 is actively recruiting participants. Visit ClinicalTrials.gov or contact Proton Collaborative Group to inquire about joining.
Where is the NCT05856773 trial being conducted?
This trial is being conducted at Scottsdale, United States, San Diego, United States, Jacksonville, United States, Miami, United States and 5 additional locations.
Who is sponsoring the NCT05856773 clinical trial?
NCT05856773 is sponsored by Proton Collaborative Group. The principal investigator is Isabelle Choi, MD at Proton Collaborative Group. The trial plans to enroll 276 participants.
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