Partial Breast Irradiation With Concurrent Chemotherapy for Women With Breast Cancer (PBI 3)
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.
Adenocarcinoma of the Breast
Other: PBI with chemotherapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||"Randomized Trial of Partial Breast Irradiation (PBI) and Sequential vs. Concurrent Chemotherapy in Women With ER Negative Early Stage Breast Cancer (PBI 3.0)"|
- Grade 3 or 4 short-term toxicity [ Time Frame: 6-7 month follow-up ] [ Designated as safety issue: Yes ]The primary endpoint will be short term (from baseline to the 6-7 month follow-up) grade 3 or 4 toxicity: confluent moist desquamation, pitting edema, ulceration, hemorrhage or necrosis. Our primary objective is to determine if chemotherapy and PBI can be given concurrently with short term toxicity comparable to standard of care, whole breast radiation (WBR) without chemotherapy, and not inferior to that of PBI plus chemotherapy given sequentially.
- 1st tumor recurrence [ Time Frame: 6-7 months ] [ Designated as safety issue: No ]Evaluate and compare any first tumor recurrence (local plus distant) between arms of the study.
- Long-term grade 3-4 toxicities [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60-66, 72-78, 84-90, 96-108, 120 ] [ Designated as safety issue: Yes ]Evaluate long term toxicity with concurrent chemotherapy and compare between arms of the study.
- Time to tumor recurrence [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60-66, 72-78, 84-90, 96-108, 120 ] [ Designated as safety issue: No ]Evaluate and compare Ipsilateral Breast Tumor Recurrence (IBTR), local recurrence, distant recurrence, and disease free survival.
- Quality of Life assessment [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60-66, 72-78, 84-90, 96-108, 120 ] [ Designated as safety issue: No ]Evaluate and compare quality of life.
- Quantify risks and benefits comparison for each arm [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60-66, 72-78, 84-90, 96-108, 120 ] [ Designated as safety issue: Yes ]Give a description of the risks and benefits observed in each arm of the study over the duration of the trial.
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Active Comparator: PBI
270 cGy (centigray) x 15
270 cGy x15
Other Name: partial breast irradiation
Experimental: PBI with chemotherapy
270 cGy (centigray) x 15 concurrent with chemotherapy of the treating medical oncologist's choice
Other: PBI with chemotherapy
270 cGy x15 concurrent with chemotherapy of the treating medical oncologist's choice
Other Name: partial breast irradiation with chemotherapy
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|Contact: Richard Zellars, MDfirstname.lastname@example.org|
|Contact: Shirley DiPasquale, RNemail@example.com|
|United States, Maryland|
|The SKCCC at Johns Hopkins||Not yet recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Richard Zellars, MD 410-502-1421 firstname.lastname@example.org|
|Contact: Shirley DiPasquale, RN 410-614-1598 email@example.com|
|Sub-Investigator: Nita Ahuja, MD|
|Sub-Investigator: Deborah Armstrong, MD|
|Sub-Investigator: Fariba Asrari, MD|
|Sub-Investigator: Melissa Camp, MD|
|Sub-Investigator: Lana De Souza Lawrence, MD|
|Sub-Investigator: Leisha Emens, MD|
|Sub-Investigator: John Fetting, MD|
|Sub-Investigator: Deborah Frassica, MD|
|Sub-Investigator: Mehran Habibi, MD|
|Sub-Investigator: Julie Lange, MD|
|Sub-Investigator: Todd McNutt, PhD|
|Sub-Investigator: Lee Myers, PhD|
|Sub-Investigator: Antonio Wolff, MD|
|Sub-Investigator: Harvey Ziessman, MD|
|Principal Investigator:||Richard Zellars, MD||The SKCCC at Johns Hopkins|