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RecruitingPhase 3

Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy

Phase III Randomized Trial of Conventionally Fractionated vs. Hypofractionated COMprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning PROton Therapy (COMPRO)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares 3 weeks of proton radiation with the standard 5 weeks of treatment. It is for women with breast cancer who need radiation to the breast or chest wall and nearby lymph nodes after surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage I–III breast cancer confirmed by a tissue test, and have had surgery to remove the cancer or the breast.
  • Need radiation to the breast or chest wall and nearby lymph nodes, including nodes near the breastbone.
  • Have no signs or suspected spread of cancer to distant parts of the body.
  • Have a health history review and physical exam within 90 days before joining.
  • Have an ECOG activity score of 0–2: able to care for yourself and be up for more than half of waking hours.
  • Have a negative pregnancy test if you could become pregnant.
  • Can start radiation within 12 weeks after your last surgery or last day of chemotherapy.
  • Breast implants, tissue expanders, and breast rebuilding surgery are allowed. Cancer in both breasts is allowed if at least one side will receive radiation to all required nearby lymph nodes.

Who can't join

  • Have inflammatory breast cancer, or breast cancer with skin sores, nearby skin lumps on the same side, or swelling such as orange-peel-like skin.
  • Have cancer still visible on scans or an exam, or cancer that has spread to distant parts of the body. An exception allows a lymph node smaller than 2 cm near the breastbone or above the collarbone that can receive extra radiation.
  • Have had radiation that overlaps the planned treatment area, or have had breast cancer before.
  • Have a tissue expander with two ports, or had an implant removed because of infection or healing problems without later rebuilding the breast with an implant or body tissue.
  • Are pregnant or breastfeeding, or have another illness that would prevent study treatment or follow-up visits.
  • Have a connective tissue disorder such as lupus or scleroderma; dermatomyositis, which affects muscles and skin; xeroderma pigmentosum, which causes extreme sun sensitivity; or an active skin rash.
  • Have a known change in the BRCA1 or BRCA2 gene.
  • Have had another invasive cancer and have not been cancer-free for at least 3 years. Exceptions include non-melanoma skin cancer, well-differentiated thyroid cancer, cancers that stayed where they began, and tumors not expected to shorten your life.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (9)

AZ

CA

FL

GA

MD

NY

VA