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)
Brief description of study.
The purpose of this study is to determine whether giving partial breast irradiation and chemotherapy at the same time has the same side effects and outcomes as giving partial breast irradiation and chemotherapy at different times.
Detailed description of study
Women with ER negative breast cancer have a higher risk of the cancer returning in the breast after whole or partial breast radiation than women with ER positive breast cancer. In a small study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy given at the same time. This combined treatment was safe and women with ER negative breast cancer did just as well as women with ER positive cancer. We are now testing in a bigger study whether giving partial breast irradiation and chemotherapy at the same time (our new method) has the same side effects and outcomes as giving partial breast irradiation and chemotherapy at different times(older method). In this study women who had their breast cancer removed but need radiation to the breast will be randomized to partial breast irradiation at the same time as chemotherapy or partial breast radiation at a different time than chemotherapy. Randomization is like flipping a coin but in this study about 2 of every 3 women will get the new method.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: ER Negative Early Stage Breast Cancer,ER negative,breast cancer,cancer,oncology
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Age: 18 years - 100 years
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Gender: Female
Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:
- Females 18 years or older
- Invasive Adenocarcinoma of the Breast
For a full list of participation criteria, please visit clinicaltrials.gov.
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.
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