Molecular Triaging of Newly Diagnosed Breast Cancer
This study has been withdrawn prior to enrollment.
(Recent developments lead to re-evaluation of study.)
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01159236
First received: July 7, 2010
Last updated: July 27, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: Paclitaxel Drug: Fluorouracil Drug: Doxorubicin Drug: Epirubicin Drug: Cyclophosphamide Drug: Bevacizumab |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Molecular Triaging of Newly Diagnosed Breast Cancer for Preoperative Therapies |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Fluorouracil
Doxorubicin
Doxorubicin hydrochloride
Paclitaxel
Epirubicin hydrochloride
Epirubicin
Bevacizumab
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Pathological Response Rate in Patients [ Time Frame: Every 3-4 weeks during chemotherapy. ] [ Designated as safety issue: No ]Response is defined as pathologic complete (pCR/RCB-0) or near complete (RCB-I) response pathologic finding after completion of chemotherapy.
| Enrollment: | 0 |
| Study Start Date: | September 2010 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1: ER-Positive
Participants with Estrogen Receptor (ER)-Positive breast cancers receive Standard T/FAC or T/FEC chemotherapy before surgery. T/FAC or T/FEC: Combination chemotherapy with sequential paclitaxel (80 mg/m2) weekly x 12 weeks followed by 5-fluorouracil (500 mg/m2), cyclophosphamide (500 mg/m2) and doxorubicin (50 mg/m2) or epirubicin (100 mg/m2) (FAC or FEC) once every 3 weeks for 4 treatments. |
Drug: Paclitaxel
80 mg/m2 by vein over about 1-2 hours once every 7 days x 12 courses.
Other Name: Taxol
Drug: Fluorouracil
500 mg/m2 for 4 courses (once every 7 days)
Other Names:
Drug: Doxorubicin
50 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments
Other Names:
Drug: Epirubicin
100 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments, may be given instead of Doxorubicin in Group 1 and 2.
Other Name: Ellence
Drug: Cyclophosphamide
500 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments.
Other Names:
|
|
Experimental: Group 2: ER-Negative
Participants with ER-negative cancers (randomized between Group 2 & Group 3), Standard T/FAC or T/FEC chemotherapy before surgery.
|
Drug: Paclitaxel
80 mg/m2 by vein over about 1-2 hours once every 7 days x 12 courses.
Other Name: Taxol
Drug: Fluorouracil
500 mg/m2 for 4 courses (once every 7 days)
Other Names:
Drug: Doxorubicin
50 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments
Other Names:
Drug: Epirubicin
100 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments, may be given instead of Doxorubicin in Group 1 and 2.
Other Name: Ellence
Drug: Cyclophosphamide
500 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments.
Other Names:
|
|
Experimental: Group 3: ER-Negative + Bevacizumab
Participants with ER-negative cancers (randomized between Group 2 & Group 3), T/FEC chemotherapy combined with 10 mg Bevacizumab every 2 weeks during first 3 treatments before surgery.
|
Drug: Paclitaxel
80 mg/m2 by vein over about 1-2 hours once every 7 days x 12 courses.
Other Name: Taxol
Drug: Fluorouracil
500 mg/m2 for 4 courses (once every 7 days)
Other Names:
Drug: Epirubicin
100 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments, may be given instead of Doxorubicin in Group 1 and 2.
Other Name: Ellence
Drug: Cyclophosphamide
500 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments.
Other Names:
Drug: Bevacizumab
10 mg/kg intravenously every 2 weeks, discontinued 6 weeks before surgery (i.e. after 3rd course of FEC or FAC)
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients 18 years of age or older with histologically confirmed HER2-normal (defined as fluorescence in situ hybridization, FISH < 2.2 or immunohistochemistry, IHC <3+ if FISH result is not available) invasive carcinoma of the breast for whom systemic adjuvant therapy is clinically indicated.
- Patients must have intact cancer in the breast and intact regional lymph nodes (diagnostic core needle or fine needle biopsies are allowed).
- Routine estrogen, progesterone and HER-2 receptor determination must be performed before starting therapy.
- Patients with prior history of breast cancer are eligible.
- Patients with bilateral breast cancers are eligible.
- Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of starting chemotherapy. Patients must agree to barrier contraception (condom) while on study.
- Patients must agree to undergo pretreatment needle biopsy of the primary tumor in the breast for molecular profiling.
- Patients must agree to undergo surgery at MDACC and if assigned to bevacizumab containing chemotherapy it must be administered at MDACC.
Exclusion Criteria:
- Patients for whom anthracycline or paclitaxel chemotherapies are contraindicated, including: uncompensated congestive heart failure, myocardial infarction within the past 12 months, pre-existing peripheral neuropathy > grade 2, prior doxorubicin therapy with > cumulative dose of 240 mg/m^2
- Women who had lumpectomy or surgical partial excisional biopsy of the cancer, or sentinel lymph node biopsy of a positive node, before starting preoperative therapy.
- Exclusion criteria for bevacizumab therapy; inadequately controlled hypertension (defined as systolic blood pressure >/= 140 mmHg and/or diastolic blood pressure >/= 90 mmHg).
- Exclusion criteria for bevacizumab therapy, prior history of hypertensive crisis or hypertensive encephalopathy, stroke or transient ischemic attacks.
- Exclusion criteria for bevacizumab therapy, history of myocardial infarction, unstable angina or congestive heart failure within 12 months prior to starting therapy.
- Exclusion criteria for bevacizumab therapy, aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis within 6 months prior to starting therapy.
- Exclusion criteria for bevacizumab therapy, history of hemoptysis ( 1/2 teaspoon of bright red blood per episode) within 1 month prior to starting therapy or evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- Exclusion criteria for bevacizumab therapy. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting therapy or core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to starting therapy.
- Exclusion criteria for bevacizumab therapy, history of abdominal fistula or gastrointestinal perforation within 6 months prior to starting therapy.
- Exclusion criteria for bevacizumab therapy, serious, non-healing wound or fracture or active ulcer.
- Proteinuria within 1 months of starting therapy as demonstrated by either (a) Urine protein:creatinine (UPC) ratio >/= 1.0 or (b) proteinuria >/= 2+ by urine dipstick test. Patients discovered to have >/=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate </= 1g of protein in 24 hours to be eligible.
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01159236 History of Changes |
| Other Study ID Numbers: | 2008-0765 |
| Study First Received: | July 7, 2010 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Gene signatures HER-2 normal stage I-III breast cancer Estrogen Receptor ER-positive ER-negative RCB categories II-III Neoadjuvant Chemotherapy adjuvant systemic therapy molecular testing Fluorouracil 5-fluorouracil 5-FU |
Doxorubicin Adriamycin Rubex Epirubicin Ellence Cyclophosphamide Cytoxan Neosar Bevacizumab Avastin Anti-VEGF monoclonal rhu-MAb-VEGF |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Bevacizumab Doxorubicin Epirubicin Paclitaxel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013