Clinical trial NCT03077841: Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer
Official title: Optimizing Preventative Adjuvant Linac-Based Radiation: The OPAL Trial a Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Ductal Breast Carcinoma In Situ
Early-Stage Breast Carcinoma
Invasive Breast Carcinoma
Stage 0 Breast Cancer AJCC v6 and v7
Stage I Breast Cancer AJCC v7
Stage IA Breast Cancer AJCC v7
Stage IB Breast Cancer AJCC v7
Stage II Breast Cancer AJCC v6 and v7
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-03-13
Enrollment: 928
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.

Detailed description: PRIMARY OBJECTIVE:

I. The risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with Optimizing Preventative Adjuvant Linac-based Radiation (OPAL) regimen.

SECONDARY OBJECTIVES:

I. To measure patient-reported cosmetic outcome, functional status, and breast pain with the OPAL regimen at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen.

II. To measure physician-reported and photographically-assessed cosmetic outcome at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen and to compare this to the best performing arm of 2010-0559.

III. To determine the 5-year risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with ductal breast carcinoma in situ (DCIS) and early invasive breast cancer.

IV. To determine the 5-year risk of any recurrence of breast cancer, disease-free survival, and overall survival.

V. To determine maximal late (within 5 years) toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale.

VI. To establish the feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.

ARM II: Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.

After completion of study treatment, patients are followed up at 6 months, and at 1.5, 3.5, and 5.5 years.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ
* Pathologic T stage of Tis, T1, or T2 with total size of tumor =\< 3 cm (this size criteria applies to both pure DCIS and invasive tumors)
* For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS
* Treatment with breast conserving surgery
* Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed
* Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded
* For invasive cancers, the tumor must be estrogen receptor positive (defined as 10% or greater expression of estrogen receptor)
* If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed at least one month prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
* Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy
* Final criteria for eligibility established after simulation: The tumor bed can be readily visualized on simulation computed tomography (CT) and is localized to one quadrant or region of the breast that is amenable to partial breast irradiation

Exclusion Criteria:

* Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature
* Any evidence of nodal positivity beyond pathologic stage of pN0(i+)
* Systemic chemotherapy prior to final breast conserving surgery
* Patient is pregnant or nursing
* History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
* History of prior invasive or in situ cancer in either breast
* Current diagnosis of bilateral breast cancer
* History of lupus or scleroderma

Primary outcomes:
measure: Risk of grade 2 or higher toxicity
timeFrame: At 6 months post radiation
Secondary outcomes:
measure: Patient-reported cosmetic outcome
timeFrame: At 6 months, one year, two years, three years, four years, and five years after completing the optimizing preventative adjuvant linac-based radiation (OPAL) regimen
measure: Physician-reported and photographically-assessed cosmetic outcome
timeFrame: At 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen
measure: Risk of pathologically-confirmed invasive and/or ipsilateral breast tumor recurrence (IBTR)
timeFrame: At 5 years
measure: Risk of any recurrence of breast cancer
timeFrame: At 5 years
measure: Disease free survival (DFS)
timeFrame: At 5 years
measure: Overall survival
timeFrame: At 5 years
measure: Incidence of adverse events
timeFrame: Up to 5 years
measure: Feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network
timeFrame: 5 years
measure: TGF-beta analysis
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Indianapolis
country: United States
facility: Community Cancer Center East
state: Indiana
city: Saginaw
country: United States
facility: Covenant Medical Center Harrison
state: Michigan
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Camden
country: United States
facility: Cooper Hospital University Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: MD Anderson Cancer Center at Cooper-Voorhees
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Hospital
state: New Mexico
city: Mansfield
country: United States
facility: OhioHealth Mansfield Hospital
state: Ohio
city: Conroe
country: United States
facility: MD Anderson in The Woodlands
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson West Houston
state: Texas
city: League City
country: United States
facility: MD Anderson League City
state: Texas
city: San Antonio
country: United States
facility: Saint Luke's Baptist Health System
state: Texas
city: Sugar Land
country: United States
facility: MD Anderson in Sugar Land
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Benjamin D Smith
role: PRINCIPAL_INVESTIGATOR
References: