PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/26/2018 |
| Start Date: | November 16, 2017 |
| End Date: | October 2020 |
| Contact: | Simona F. Shaitelman, MD |
| Email: | sfshaitelman@mdanderson.org |
| Phone: | 713-563-2300 |
The goal of this clinical research study is to compare changes to the tumor(s) in your breast
before and after radiation.
Radiation treatment is standard treatment after surgery for women with breast cancer. This
radiation treatment is typically delivered to the larger breast area for 3-5 weeks of
treatment, followed by 1 week of treatment (called a radiation boost) to the area where the
tumor used to be. In this study, the radiation boost will be given before surgery rather than
after it.
Researchers want to learn about how radiation changes the immune system's response to the
tumor, about side effects that develop after radiation treatment, and how radiation kills
breast cancer cells.
This is an investigational study. The radiation treatment will be delivered using
FDA-approved and commercially available methods. The timing of the radiation boost is
considered investigational.
Up to 20 participants will be enrolled in this study. All will be enrolled at MD Anderson.
before and after radiation.
Radiation treatment is standard treatment after surgery for women with breast cancer. This
radiation treatment is typically delivered to the larger breast area for 3-5 weeks of
treatment, followed by 1 week of treatment (called a radiation boost) to the area where the
tumor used to be. In this study, the radiation boost will be given before surgery rather than
after it.
Researchers want to learn about how radiation changes the immune system's response to the
tumor, about side effects that develop after radiation treatment, and how radiation kills
breast cancer cells.
This is an investigational study. The radiation treatment will be delivered using
FDA-approved and commercially available methods. The timing of the radiation boost is
considered investigational.
Up to 20 participants will be enrolled in this study. All will be enrolled at MD Anderson.
If you agree to take part in this study, you will have an ultrasound of the breast to check
the status of the disease.
Leftover tumor tissue from the biopsy performed to diagnose you (called a diagnostic biopsy),
if available, will be collected. This is collected so researchers have a baseline (control)
sample to compare to the results of testing performed later in this study.
Then, if there is enough tissue to biopsy, image-guided biopsies will be taken of the tumor
in the breast. Depending on how you feel, up to 6 biopsies will be performed. To perform an
image-guided biopsy, a needle is inserted into the affected area using an ultrasound to
collect cells or tissue from the tumor. The doctor will use the imaging to guide the needle
into the area. Two (2) types of samples will be collected. A single fine needle aspirate will
collect cells and up to 5 core biopsies will be performed to collect small pieces of tissue.
If it is found that there is not enough tissue to biopsy, then you will not have these
biopsies, and you will be taken off study.
You will have blood drawn (about 1 teaspoon each time) for tests of your immune system:
- On the same day as your biopsies
- At the time of surgery, while you are in the operating room
About 6 to 8 days before your surgery, you will receive the radiation boost. The radiation
boost will be delivered in a similar way it would if you were to receive it after surgery.
You will have an MRI done before surgery.
You will then have your surgery and radiation therapy as scheduled.
You will receive separate consent forms for the radiation therapy and surgery that explains
the procedures and the risks.
Information about any side effects you may be having from radiation and/or surgery will be
collected from your medical record for up to 6 months after the end of radiation.
Length of Study:
Your participation on this study will be over after your standard, 6-month follow-up visit
after the end of radiation therapy.
the status of the disease.
Leftover tumor tissue from the biopsy performed to diagnose you (called a diagnostic biopsy),
if available, will be collected. This is collected so researchers have a baseline (control)
sample to compare to the results of testing performed later in this study.
Then, if there is enough tissue to biopsy, image-guided biopsies will be taken of the tumor
in the breast. Depending on how you feel, up to 6 biopsies will be performed. To perform an
image-guided biopsy, a needle is inserted into the affected area using an ultrasound to
collect cells or tissue from the tumor. The doctor will use the imaging to guide the needle
into the area. Two (2) types of samples will be collected. A single fine needle aspirate will
collect cells and up to 5 core biopsies will be performed to collect small pieces of tissue.
If it is found that there is not enough tissue to biopsy, then you will not have these
biopsies, and you will be taken off study.
You will have blood drawn (about 1 teaspoon each time) for tests of your immune system:
- On the same day as your biopsies
- At the time of surgery, while you are in the operating room
About 6 to 8 days before your surgery, you will receive the radiation boost. The radiation
boost will be delivered in a similar way it would if you were to receive it after surgery.
You will have an MRI done before surgery.
You will then have your surgery and radiation therapy as scheduled.
You will receive separate consent forms for the radiation therapy and surgery that explains
the procedures and the risks.
Information about any side effects you may be having from radiation and/or surgery will be
collected from your medical record for up to 6 months after the end of radiation.
Length of Study:
Your participation on this study will be over after your standard, 6-month follow-up visit
after the end of radiation therapy.
Inclusion Criteria:
1. Age >/=18 years at time of study entry
2. Histologically confirmed HR+/HER2- (according to American Society of Clinical
Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast
3. Presence of a clip in the primary breast cancer
4. Biopsy-amenable residual disease in the breast measuring >/= 1cm in at least one
dimension on ultrasound cm in at least one dimension on ultrasound
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Signed written informed consent
7. Planned for multidisciplinary evaluation by a Breast Surgical Oncologist and Breast
Radiation Oncologist. For patients undergoing mastectomy and desirous of
reconstruction or those undergoing breast conservation in whom oncoplastic local
tissue rearrangement or reduction mammoplasty is being considered, this
multidisciplinary evaluation will also include a plastic surgeon.
Exclusion Criteria:
1. Women who are pregnant or breast-feeding
2. Contraindication to receive radiotherapy
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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