The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial Of PreoperAtive Radiation (TOPAz): A Randomized Trial Comparing Hypofractionated Versus Conventionally Fractionated Preoperative Radiation Followed by Mastectomy With Immediate Autologous Breast Reconstruction With Integrated Nanomechanical Biomarker Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05774678
Recruitment Status : Recruiting
First Posted : March 20, 2023
Last Update Posted : June 6, 2024
Sponsor:
Collaborator:
Artidis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
To compare the outcomes of and responses to 2 different radiation therapy schedules (the standard radiation amount and number of doses versus less radiation and fewer doses) that are being given before having breast cancer surgery (cancer removal and reconstruction).

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Group 1 (preoperative radiation hypofractionated) Other: Group 2 (preoperative radiation conventionally fractionated) Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial Of PreoperAtive Radiation (TOPAz): A Randomized Trial Comparing Hypofractionated Versus Conventionally Fractionated Preoperative Radiation Followed by Mastectomy With Immediate Autologous Breast Reconstruction With Integrated Nanomechanical Biomarker Evaluation
Actual Study Start Date : April 5, 2023
Estimated Primary Completion Date : November 1, 2026
Estimated Study Completion Date : November 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: Group 1 (preoperative radiation hypofractionated)
Participants will receive the standard number of radiation treatment doses
Radiation: Group 1 (preoperative radiation hypofractionated)
radiation schedules/regimens before your scheduled breast surgery

Other: Group 2 (preoperative radiation conventionally fractionated)
radiation schedules/regimens before your scheduled breast surgery

Experimental: Group 2 (preoperative radiation conventionally fractionated)
Participants will receive the standard number of radiation treatment doses
Radiation: Group 1 (preoperative radiation hypofractionated)
radiation schedules/regimens before your scheduled breast surgery

Other: Group 2 (preoperative radiation conventionally fractionated)
radiation schedules/regimens before your scheduled breast surgery




Primary Outcome Measures :
  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Histologic diagnosis of invasive breast cancer (cytologic or histologic confirmation of nodal metastasis is sufficient to establish this eligibility criteria).
  • Clinical and/or pathologic stage T3-T4c OR N1-N3; for the IBC pilot cohort only, the stage requirement is T4d, any N, M1
  • Mastectomy is the planned oncologic surgery but has not yet been performed at the time of protocol enrollment
  • Autologous (i.e. tissue-based) reconstruction is planned with either a free or rotational flap.
  • For patients with HER2 positive, non-IBC breast cancer treated with neoadjuvant chemotherapy, one of the following criteria must be met:

    1. Residual invasive disease should be documented in either the breast or a regional nodal metastasis after neoadjuvant chemotherapy. This specific eligibility criteria can be satisfied by the post-chemotherapy standard of care breast biopsy. For this matter, the patient may be enrolled on the trial prior to biopsy. If the biopsy does not show residual invasive disease, then the patient will not proceed with protocol-directed therapy and will be removed and replaced from the study.
    2. Medical oncologist has documented a discussion in the chart about potential risks of proceeding with PreMRT with regard to impact on adjuvant systemic therapy decisions and the patient has opted to proceed with trial enrollment
  • For T4d pilot cohort patients, post-chemotherapy, pre-radiation ultrasound must demonstrate at least partial response in the breast and regional lymph nodes and no suspicious infraclavicular, internal mammary, and supraclavicular lymph nodes.
  • Ability to provide written informed consent in accordance with institutional policies.

Exclusion Criteria:

  • Patients undergoing treatment for recurrent breast cancer in the index breast or lymph nodes.
  • History of therapeutic irradiation to the breast, lower neck, mediastinum or other area(s) that will overlap with the affected breast.
  • Presence of active scleroderma
  • Patients who are pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05774678


Contacts
Layout table for location contacts
Contact: Benjamin D. Smith, MD (713) 563-2380 bsmith3@mdanderson.org

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Benjamin D. Smith, MD    713-563-2380    bsmith3@mdanderson.org   
Principal Investigator: Benjamin D. Smith, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Artidis
Investigators
Layout table for investigator information
Principal Investigator: Benjamin D. Smith, MD M.D. Anderson Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05774678    
Other Study ID Numbers: 2022-0880
NCI-2023-01985 ( Other Identifier: NCI-CTRP Clinical Trials Registry )
First Posted: March 20, 2023    Key Record Dates
Last Update Posted: June 6, 2024
Last Verified: June 2024

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No