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 Tissue Nanomechanical Phenotype Evaluation

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Group 1 (preoperative radiation hypofractionated)

    Radiation

    radiation schedules/regimens before your scheduled breast surgery

  • Group 2 (preoperative radiation conventionally fractionated)

    Other intervention

    radiation schedules/regimens before your scheduled breast surgery

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Group 1 (preoperative radiation hypofractionated)Experimental treatment 2 interventions
Group B: Group 2 (preoperative radiation conventionally fractionated)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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