Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03137693
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 25.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR). The purpose of this study is to evaluate the effects, good and/or bad, of pre-operative SABR specifically focusing on its ability to reduce the chances that additional breast surgery will be needed, reducing the amount of breast/heart/lung tissue that is irradiated, and to study the tumor-tissue effects of SABR. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Breast Cancer Female; Breast Adenocarcinoma	Other: Standard of Care Schedule Variation: SABR; Procedure: Breast-conserving Surgery	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer: Introduction of a Novel Form of Accelerated Partial Breast Radiotherapy
• Actual Study Start Date: Nov 29, 2017
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Jan 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Change in Procedure Scheduling Pre-Surgery SABR: Treatment with Stereotactic Ablative Body Radiation Therapy (SABR) followed by breast-conserving surgery. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.	Other: Standard of Care Schedule Variation: SABR; SABR will be delivered over 3 days, prior to surgery.; Other Names: radiotherapy Stereotactic Ablative Body Radiation Therapy (SABR) ; Procedure: Breast-conserving Surgery; Breast-conserving surgery will be scheduled for 6-8 weeks after SABR and will be conducted by a Moffitt breast surgeon.

Outcome Measures

Primary Outcome Measures

1. Rate of Pathologic Complete Response (pCR) [6 weeks post SABR]

   Rate of pathologic complete response following pre-operative SABR for early-stage breast carcinoma. pCR: The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of the neoadjuvant treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Understand and voluntarily sign an informed consent document prior to conducting any study related assessments or procedures.

• Histologically proven invasive adenocarcinoma of breast.

• Must have marker clip indicating location of target tumor in breast.

• Unifocal tumor less than or equal to 2 cm based on contrast-enhanced prone-breast MRI.

• Must be clinically and radiographically node negative (N0) to participate on this protocol. Clinically suspicious regional nodes by imaging or physical exam require biopsy evaluation to exclude disease involvement.

• Appropriate candidate for breast-conserving surgery based on multi-disciplinary assessment.

• Females age ≥ 50 years.

• Able to tolerate prone body positioning during radiation therapy.

• No prior ipsilateral-breast or thoracic radiotherapy.

• As defined on MRI, target lesion must be at least 10 mm distance from skin (defined as volume encompassing first 3 mm from breast surface).

• Must be estrogen receptor (ER) positive.

• Must be negative for Her-2 amplification. (Either 1+ on semi-quantitative evaluation of immunostain or negative by fluorescent in-situ hybridization).

• No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion.

• No history of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years.

• Must not have received nor be planned for neoadjuvant chemotherapy prior to SABR or surgery.

• ECOG performance status less than 2.

• Females of childbearing potential must have a negative urine pregnancy test prior to simulation and within seven days of SABR start.

Exclusion Criteria:

• Have invasive lobular carcinoma.

• Have a Tumor > 2 cm as measured on prone contrast-enhanced breast MRI.

• Have presence of histologically proven lymph node disease.

• Are not a candidate for breast conserving surgery.

• Have had prior ipsilateral-breast or thoracic radiotherapy.

• History of scleroderma or lupus erythematosus with either cutaneous manifestation or requiring active treatment.

• An MRI defined target tumor that is within 10 mm of skin (defined as volume encompassing first 3 mm from skin surface).

• Have amplification of Her-2 (Either 3+ by semi-quantitative immunostain or positive by Fluorescent in-situ hybridization (FISH)).

• Have implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion.

• History of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years.

• Have received or plan to receive neoadjuvant chemotherapy either before radiotherapy or before surgery.

• A known carrier of BRCA1 or BRCA2 gene mutation.

• Pregnant or unwilling to undergo pregnancy screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612

Sponsors and Collaborators

• H. Lee Moffitt Cancer Center and Research Institute

Investigators

• Principal Investigator: Michael Montejo, H. Lee Moffitt Cancer Center and Research Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 30, 2020

More Information

Additional Information:

• Moffitt Cancer Center Clinical Trials website

Publications

None provided.

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT03137693
• Other Study ID Numbers: MCC-18596
• First Posted: May 3, 2017
• Last Update Posted: Apr 28, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by H. Lee Moffitt Cancer Center and Research Institute: histologically proven; invasive adenocarcinoma of breast; node negative (N0); breast-conserving surgery; negative for Her-2 amplification; estrogen receptor (ER) positive; progesterone receptor (PR) positive
• Additional relevant MeSH terms: Breast Neoplasms; Adenocarcinoma

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 45%
>=65 years	11 55%
Sex: Female, Male (Count of Participants)
Female	20 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 15%
Not Hispanic or Latino	17 85%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	19 95%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Rate of Pathologic Complete Response (pCR)
Description	Rate of pathologic complete response following pre-operative SABR for early-stage breast carcinoma. pCR: The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of the neoadjuvant treatment.
Time Frame	6 weeks post SABR

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
Measure Participants	20
Number [percentage of participants]	0 0%

Adverse Events

Time Frame	1 year, 11 months
Arm/Group Title	All Participants
Arm/Group Description	All participants who received Stereotactic Ablative Body Radiotherapy (SABR) prior to breast surgery
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	3/20 (15%)
General disorders
Pain	2/20 (10%)	2
Infections and infestations
Infections and Infestations - Other	1/20 (5%)	1
Injury, poisoning and procedural complications
Dermatitis radiation	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.