Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer

Anatomic Stage II Breast Cancer AJCC v8 Clinical Trial

Official title:

A Single Center Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871516
• Other study ID #: Pro2020001306
• Secondary ID: NCI-2020-05711Pr
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• 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

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Radiation:
• Radiation Boost
Undergo radiation therapy boost

Procedure:
• Therapeutic Surgical Procedure
Undergo standard surgery

Radiation:
• Whole Breast Irradiation
Undergo standard WBI

Other:
• Breast MRI
A baseline breast MRI

Locations

Country	Name	City	State
United States	Clara Maass Medical Center	Belleville	New Jersey
United States	RWJBarnabas Health-Trinitas Hospital and Comprehensive Care	Elizabeth	New Jersey
United States	The Cancer Institute of New Jersey Hamilton	Hamilton	New Jersey
United States	RWJBarnabas Health Jersey City Medical Center	Jersey City	New Jersey
United States	RWJBarnabas Health - Monmouth Medical Center Southern Campus	Lakewood	New Jersey
United States	Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)	Livingston	New Jersey
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Rutgers New Jersey Medical School	Newark	New Jersey
United States	RWJBarnabas Health - Newark Beth Israel Medical Center	Newark	New Jersey
United States	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey
United States	RWJBarnabas Health - Community Medical Center	Toms River	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute and late radiation toxicity	Rate of fibrosis, rate of telangiectasia formation and rate of radiation dermatitis will be assessed by the radiation oncologist using descriptions and grading scales found in the NCI CTCAE v5.0. Will also assess changes in pathology between the biopsy and the surgical specimen.	Up to 24 months after WBI
Other	Patient reported cosmesis	Patient reported cosmesis will be assessed by the patient using the Breast Cancer Treatment Outcomes Scale (BCTOS).	At 1 month after WBI
Other	Patient reported cosmesis	Patient reported cosmesis will be assessed by the patient using the Breast Cancer Treatment Outcomes Scale (BCTOS).; Breast Cancer Treatment Outcome Scale is a questionnaire designed to assess women's subjective evaluation of both the aesthetic and functional outcome after breast cancer treatment. Patients are instructed to rate each item of the BCTOS questionnaire on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference to 4 = large difference). Higher scores reflect worse outcomes.	At 12 months after WBI
Other	Patient reported cosmesis	Patient reported cosmesis will be assessed by the patient using the Breast Cancer Treatment Outcomes Scale (BCTOS).; Breast Cancer Treatment Outcome Scale is a questionnaire designed to assess women's subjective evaluation of both the aesthetic and functional outcome after breast cancer treatment. Patients are instructed to rate each item of the BCTOS questionnaire on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference to 4 = large difference). Higher scores reflect worse outcomes.	At 24 months after WBI
Other	Clinical target volume (CTV)	The difference between the pre-operative boost Clinical target volume (CTV) and the post-op Clinical target volume (CTV) volume that would have been contoured as Clinical target volume (CTV) if the boost was to be delivered post-operatively.	Measured 1-5 weeks prior to surgery and measured 1-7 weeks after surgery
Other	Tumor histology and pathologic response	Another goal is to look into the histopathology of tumors before and after radiation to assess response and other immunologic changes to the tumor and the tumor environment elicited by the radiation treatment.	Up to 24 months after WBI
Primary	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.	Wound complications will be assessed by the surgeon and radiation oncologist and graded using descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE v 5.0). This will be calculated as a proportion based on the number of events in the study. Will report the proportion with a 95% confidence interval (CI) using the Clopper-Pearson method.	For at least 36 months after WBI
Secondary	Physician reported cosmesis	Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor).	At 1 month after whole breast irradiation (WBI)
Secondary	Physician reported cosmesis	Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor).	At 12 months after WBI
Secondary	Physician reported cosmesis	Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor). Will be reported as a proportion; CI will be calculated using the Clopper-Pearson model.	At 36 months after WBI