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A Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women with ER Negative Early Stage Breast Cancer (PBI 3.0)

Investigating Timing of Partial Breast Irradiation and Chemotherapy (Cancer Treatment)

Recruiting
18 years and older
Female
Phase N/A

This study investigates the effects of giving partial breast irradiation and chemotherapy at the same time compared to giving them at different times for women with breast cancer. Breast cancer can be categorized by hormone receptor status, such as estrogen receptor (ER) negative or positive. Previous studies have shown that women with ER negative breast cancer might have a higher risk of cancer returning after radiation. This study aims to determine if the timing of these treatments affects side effects and outcomes for these patients.

Participants in the study will undergo either simultaneous partial breast irradiation and chemotherapy or receive these treatments at different times. The study uses randomization, which means participants are randomly assigned to one of the study arms, similar to flipping a coin. However, approximately two out of every three women will receive the simultaneous treatment method. This study aims to compare the safety and effectiveness of the two treatment approaches.

  • Who can participate: Women aged 18 years or older with invasive adenocarcinoma of the breast are eligible to participate. Additional criteria may apply, and interested individuals should consult the full list of eligibility requirements.
  • Study details: Participants will receive either partial breast irradiation and chemotherapy at the same time or at different times.
Study details
    ER Negative Early Stage Breast Cancer
    ER negative
    breast cancer
    cancer
    oncology

TX5321

19 February 2024

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