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Clinical Trial 21757

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT05528133

Phase: Phase II
Principal Investigator: Ahmed, Kamran

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer

Summary

The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.

Objective

Primary Objective: To determine the three year local control following genomically guided dose escalation in the management of triple negative (TN) breast cancer following BCT. Secondary Objectives: To determine the overall survival (OS) following genomically guided dose escalation in the management of TN breast cancer following BCT. To determine the progression free survival (PFS) following genomically guided dose escalation in the management of TN breast cancer following BCT. To determine the distant control (DC) rate following genomically guided dose escalation in the management of TN breast cancer following BCT. To determine safety following genomically guided dose escalation in the management of TN breast cancer following BCT. To determine quality of life (QOL) following genomically guided dose escalation in the management of TN breast cancer following BCT.

Treatments

Therapies

Radiotherapy

Medications

Radiotherapy ()

Inclusion Criteria

Inclusion Criteria:

Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection

Confirmation of Triple Negative (TN) breast cancer by tissue biopsy

Adequate tissue to calculate RSI

To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines

To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (> For patients undergoing neoadjuvant chemotherapy, residual tumor burden should be noted. For patients with a pathologic complete response in which RSI cannot be calculated they will remain eligible for assessment of tertiary objectives

Life expectancy >16 weeks

KPS >70

Age >18 years

Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon

There is no limit on prior systemic therapies

Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study

Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment

Other criteria may apply

Exclusion Criteria

Exclusion Criteria:

Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation

Women who are pregnant or breastfeeding

Positive surgical margins

History of allergy or hypersensitivity to any of the study drugs or study drug components

Metastatic breast cancer

Other exclusions may apply

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.