Breast Cancer Clinical Trial
Official title:
Molecular Triaging of Newly Diagnosed Breast Cancer for Preoperative Therapies
The goal of this clinical research study is to learn if using "gene signatures" can be an effective way to decide the best treatment for breast cancer patients. Gene signatures may be able to help researchers predict who will respond to chemotherapy given before surgery.
At this time, treatment of stage I-III breast cancer for patients who are at high risk for
the cancer returning is surgery and chemotherapy. If the cancer is positive for estrogen
hormone receptor, patients also have endocrine therapy.
The most common standard chemotherapy treatment regimens for breast cancer at M. D. Anderson
are paclitaxel (T), followed by treatments with fluorouracil (F), doxorubicin (A) or
epirubicin (E), and cyclophosphamide (C). These chemotherapy combinations are known as T/FAC
and T/FEC. However, not all patients respond to these treatments, so researchers at M. D.
Anderson have developed tests to predict how much a person's breast cancer might respond to
T/FAC or T/FEC chemotherapy.
Fine needle aspiration (FNA) of the tumor are collected after numbing the skin of the breast
with local anesthesia, and the genes within the FNA sample are measured to calculate the
results of treatment prediction tests before treatment is selected.
In this research study, the gene-based tests will help to select treatment based on the
predictions of response to chemotherapy, and to then measure the tumor response from the
surgery after the treatment.
Study Drugs:
T/FAC and T/FEC are designed to damage the DNA (genetic material of cells), which may cause
cancer cells to die.
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary
for tumor growth. This may prevent or slow down the growth of cancer cells and make them
more susceptible to chemotherapy.
Tumor Biopsies:
If you are found eligible to take part in this study, you will have 3-4 fine needle biopsies
of the tumor collected. The skin over the tumor and the breast tissues surrounding the tumor
will be numbed using local anesthesia. To perform fine needle aspiration biopsies, tumor
cells are withdrawn from the tumor using a very thin needle alone, or using a syringe.
These biopsies will be used to measure different genes and to predict how the cancer may
respond to different treatments.
Based on the information from these gene measurements, a computer model will predict if the
cancer is highly sensitive to chemotherapy and is likely to shrink to a great extent or
disappear completely due to chemotherapy. This response prediction is done separately for
estrogen receptor-positive and estrogen receptor-negative cancers.
Study Groups:
If the biopsies show that the cancer may respond well to standard T/FAC or T/FEC
chemotherapy, you will receive the chemotherapy before surgery (Group 1).
If the biopsies show that the cancer may not respond as well to standard T/FAC or T/FEC
chemotherapy, you will be randomly assigned (as in the roll of dice) to 1 of 2 groups.
- If you are in Group 2, you will receive T/FAC or T/FEC chemotherapy before surgery. One
(1) out of 3 participants whose cancer may not respond as well will be assigned to this
group.
- If you are in Group 3, you will receive T/FAC or T/FEC chemotherapy combined with
bevacizumab before surgery. Two (2) out of 3 participants whose cancer may not respond
as well will be assigned to this group.
Your doctor will decide if you receive T/FAC or T/FEC.
Study Drug Administration:
Groups 1 and 2:
Once a week during Weeks 1-12, you will receive paclitaxel by vein over about 1-2 hours.
Once every 3 weeks during Weeks 13-24, you will receive T/FAC or T/FEC by vein over about
3-4 hours. This chemotherapy treatment is considered routine standard of care and you may
receive this treatment closer to home outside of M. D. Anderson.
After all chemotherapy, you will have surgery at M. D. Anderson to remove the cancer.
Group 3:
Once a week during Weeks 1-12, you will receive paclitaxel by vein over about 1-2 hours.
Once every 2 weeks during Weeks 1-18, you will receive bevacizumab by vein once over about
1-2 hours. If your doctor thinks is it necessary, and based on heart related test results,
you may only receive bevacizumab during Weeks 1-12.
Once every 3 weeks during Weeks 13-24, you will receive T/FAC or T/FEC by vein over about 4
hours. You must receive your chemotherapy at M. D. Anderson if you are in this group.
After all chemotherapy, you will have surgery at M. D. Anderson to remove the cancer.
Study Visits:
All participants will have routine visits at M. D. Anderson at least once every 12 weeks
during chemotherapy. Your doctor will determine the tests and procedures to be performed.
If you are assigned to Group 3, you will also have the following additional procedures.
- You will have a urine analysis within 1 month after starting therapy.
- You will have an echocardiogram to check your heart's health within 3 months after you
begin treatment.
Length of Study:
You may receive chemotherapy for up to 6 months. Once surgery is performed, your
participation in this study is complete. Your doctor will decide together with you what
further treatment you will need after surgery.
This is an investigational study. The biopsy and testing to predict response to chemotherapy
is not FDA approved or commercially available. Its use in this study is investigational. The
chemotherapy and surgery are standard of care for patients with breast cancer. The addition
of bevacizumab to treatment is also investigational.
Up to 303 patients will take part in this study. All will be enrolled at M. D. Anderson.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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