Breast Cancer Clinical Trial

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

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.

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Full 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

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

55

Study ID:

NCT04871516

Recruitment Status:

Recruiting

Sponsor:

Rutgers, The State University of New Jersey

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There are 4 Locations for this study

See Locations Near You

The Cancer Institute of New Jersey Hamilton
Hamilton New Jersey, 08690, United States More Info
Rachana Singh
Contact
609-584-2801
[email protected]
Rachana Singh
Principal Investigator
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States More Info
Bruce G. Haffty
Contact
732-253-5203
[email protected]
Bruce G. Haffty
Principal Investigator
Rutgers New Jersey Medical School
Newark New Jersey, 07101, United States More Info
Bruce G. Haffty
Contact
732-253-5203
[email protected]
Bruce G. Haffty
Principal Investigator
Robert Wood Johnson University Hospital Somerset
Somerville New Jersey, 08876, United States More Info
Laura R. Bond
Contact
908-268-5248
[email protected]
Laura R. Bond
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

55

Study ID:

NCT04871516

Recruitment Status:

Recruiting

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

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