Clinical trial NCT04871516: Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer
Official title: A Single Center Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Invasive Breast Carcinoma
Non-Metastatic Breast Carcinoma
Prognostic Stage 0 Breast Cancer AJCC v8
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-04
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.

Detailed description: PRIMARY OBJECTIVE:

I. To demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic node negative breast cancer who are eligible for breast conserving surgery (BCS) and treated with pre-operative radiation boost at 1 month after end of whole breast radiation is no worse than the rates in the current standard of care (6-20%).

SECONDARY OBJECTIVE:

I. To demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated whole breast irradiation (WBI).

TERTIARY/EXPLORATORY OBJECTIVES:

I. To measure the acute and late radiation related toxicities such as radiation dermatitis, telangiectasia and fibrosis in this cohort of patients.

II. To measure the pre-operative boost clinical target volume (CTV) and compare to the post-op CTV volume that would have been contoured as CTV if the boost was to be delivered post-operatively.

III. To measure the incidence of fair/poor patient reported cosmetic outcome using the Breast Cancer Treatment Outcomes Scale (BCTOS) cosmetic scale.

IV. To study the cancer biology before and after radiation treatment.

OUTLINE:

Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 18, and 24 months

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients with biopsy proven invasive cancer
* Clinically and radiographically node negative
* No indication of metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Synchronous bilateral invasive cancer allowed
* Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery
* Willingness to participate in the clinical trial and adhere to the study protocol
* Individuals of all races, genders and ethnic groups are eligible for this trial

Exclusion Criteria:

* Need for neoadjuvant chemotherapy
* Inflammatory breast cancer (cT4)
* Multicentric tumor
* Prior ipsilateral breast or thoracic RT
* Contraindication for baseline magnetic resonance imaging (MRI)
* Contraindication for surgery
* Distant metastatic disease
* Other synchronous cancer (besides bilateral breast)
* Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease)
* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results

Primary outcomes:
measure: Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.
timeFrame: For at least 36 months after WBI
Secondary outcomes:
measure: Physician reported cosmesis
timeFrame: At 1 month after whole breast irradiation (WBI)
measure: Physician reported cosmesis
timeFrame: At 12 months after WBI
measure: Physician reported cosmesis
timeFrame: At 36 months after WBI
Other outcomes:
measure: Acute and late radiation toxicity
timeFrame: Up to 24 months after WBI
measure: Patient reported cosmesis
timeFrame: At 1 month after WBI
measure: Patient reported cosmesis
timeFrame: At 12 months after WBI
measure: Patient reported cosmesis
timeFrame: At 24 months after WBI
measure: Clinical target volume (CTV)
timeFrame: Measured 1-5 weeks prior to surgery and measured 1-7 weeks after surgery
measure: Tumor histology and pathologic response
timeFrame: Up to 24 months after WBI
Locations:
city: Belleville
country: United States
facility: Clara Maass Medical Center
state: New Jersey
city: Elizabeth
country: United States
facility: RWJBarnabas Health-Trinitas Hospital and Comprehensive Care
state: New Jersey
city: Hamilton
country: United States
facility: The Cancer Institute of New Jersey Hamilton
state: New Jersey
city: Jersey City
country: United States
facility: RWJBarnabas Health Jersey City Medical Center
state: New Jersey
city: Lakewood
country: United States
facility: RWJBarnabas Health - Monmouth Medical Center Southern Campus
state: New Jersey
city: Livingston
country: United States
facility: Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Newark
country: United States
facility: RWJBarnabas Health - Newark Beth Israel Medical Center
state: New Jersey
city: Somerville
country: United States
facility: Robert Wood Johnson University Hospital Somerset
state: New Jersey
city: Toms River
country: United States
facility: RWJBarnabas Health - Community Medical Center
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Bruce G Haffty
role: PRINCIPAL_INVESTIGATOR
References: