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

Breast Cancer Clinical Trial

— COMPRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856773
• Other study ID #: BRE009-23
• Status: Recruiting
• Phase: Phase 3
• Start date: March 21, 2024
• Est. completion date: February 2041

Study information

• Verified date: May 2024
• Source: Proton Collaborative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is being done to see if comprehensive regional nodal radiation therapy to the breast or chest wall and regional lymph node area using proton therapy delivered with a hypofractionated approach (less treatment days) will result in rates of treatment related skin and soft tissue side effects that are non-inferior compared to conventionally fractionated proton radiotherapy regimens.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: February 2041
• Est. primary completion date: February 2038
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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, 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
• Documentation of negative metastatic workup by whole body Positron Emission Tomography
• Computed Tomography (PET/CT) or by combined CT of the chest, abdomen, pelvis and Bone scan
• 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 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Proton Therapy
Pencil Beam Scanning (PBS)

Locations

Country	Name	City	State
United States	New York Proton Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Proton Collaborative Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To correlate dosimetric parameters with acute and late adverse events for the development of model dose constraints for comprehensive nodal irradiation for breast cancer using a moderately hypofractionated regimen with PBS-PT		2, 5, and 10 years after radiation therapy
Primary	To determine if the rate of grade =3 treatment-related skin and soft tissue toxicities with comprehensive nodal irradiation for breast cancer using hypofractionated PBS proton therapy is non-inferior to conventionally-fractionated proton radiotherapy	This study will investigate if adjuvant comprehensive regional nodal radiotherapy to the breast or chest wall and regional lymph nodes including the axilla (levels I-III), supraclavicular (SCV), and internal mammary (IMN) lymph nodes using pencil beam scanning proton therapy delivered with a hypofractionated regimen results in rates of acute and late grade 3 or worse treatment-related skin and soft tissue toxicities that are non-inferior compared with rates in pencil beam scanning proton therapy using conventionally fractionated regimens.	2 years after radiation therapy
Secondary	To determine the rate of any grade =3 treatment-related adverse events		2, 5, and 10 years after radiation therapy
Secondary	To determine local recurrence rates		2, 5, and 10 years after radiation therapy
Secondary	To determine regional recurrence rates		2, 5, and 10 years after radiation therapy
Secondary	To determine distant recurrence rates		2, 5, and 10 years after radiation therapy
Secondary	To determine breast cancer-specific survival		2, 5, and 10 years after radiation therapy
Secondary	To determine overall survival		2, 5, and 10 years after radiation therapy
Secondary	To assess patient-reported quality of life	FACT-B questionnaire	2, 5, and 10 years after radiation therapy
Secondary	To assess patient-reported quality of life	BREAST-Q questionnaire	2, 5, and 10 years after radiation therapy
Secondary	To assess physician-reported cosmetic outcomes	Physician reported cosmesis form	2, 5, and 10 years after radiation therapy