Breast Cancer study: Proton Therapy
Official title Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy
ClinicalTrials.gov ID: NCT05856773
What this study is testing
- What it's testing
- This study aims to find out if treating breast cancer with proton radiation over 3 weeks is just as effective as the standard 5-week treatment.
- Who it's for
- The study is looking for women with breast cancer who need radiation therapy to their chest wall and nearby lymph nodes.
- What's involved
- Participants will receive proton radiation therapy, either in a shorter 3-week schedule or the standard 5-week schedule.
- Time commitment
- The treatment lasts either 3 or 5 weeks, depending on which group you are assigned to.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older, women only
You may be able to join if
- Patients with Stage I-III breast cancer who have undergone breast conserving surgery or mastectomy and have been recommended to receive postoperative...
- Histologically documented breast cancer (invasive mammary, ductal, medullary, tubular, metaplastic, mucinous, lobular, or ductal carcinoma in situ)...
- 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
You likely can't join if
- Presence of skin ulceration and / or ipsilateral satellite nodules and/or edema (including peau d'orange) (T4b or T4c disease) or diagnosis of...
- Residual gross disease detected by imaging or clinical exam with the exception of \<2cm internal mammary lymph node or supraclavicular lymph node...
- Prior history of radiation therapy overlapping with current target volume (including intraoperative brachytherapy, interstitial catheter...
- 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
See the full eligibility 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...
- 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- San Diego, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; San Diego, California, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.