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Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer

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ClinicalTrials.gov Identifier: NCT00256243
Recruitment Status : Completed
First Posted : November 21, 2005
Results First Posted : March 17, 2014
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Rita Sanghvi, Mehta, University of California, Irvine

Brief Summary:
We proposed to use 4 cycles of AC q 2 weeks, as used in the dose dense adjuvant study with GM-CSF support on days 3-9 of the cycle. After the completion of AC we plan to administer paclitaxel and carboplatin weekly for a total of 12 doses with one week rest after every 3 weeks of treatment over 12 weeks. Patients who are her-2 over-expressors by FISH (fluorescence in situ hybridization) will also receive Trastuzumab with weekly carboplatin and paclitaxel as the combination TC±H has been found to be synergistic in advanced breast cancer with improved clinical outcome.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Doxorubicin Drug: Cyclophosphamide Drug: Paclitaxel Drug: Carboplatin Drug: GM-CSF Drug: Trastuzumab Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide (AC) With GMCSF Followed by Weekly Carboplatin/Paclitaxel With Plus or Minus Trastuzumab (TC ± H) in the Treatment of Breast Cancer
Study Start Date : April 2004
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Chemotherapy with GM-CSF

Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)

This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.

Patients who are her-2 overexpressors by FISH will also receive Trastuzumab with weekly carboplatin and paclitaxel as the combination has been found to be synergistic in advanced breast cancer with improved clinical outcome.

Drug: Doxorubicin
60 mg/m2 IV, bolus once every 14 days x 2-4 cycles
Drug: Cyclophosphamide
600 mg/m2 IV once every 14 days x 2-4 cycles
Drug: Paclitaxel
80 mg/m2 IV over 1 hour once weekly for 9-12 doses beginning two weeks after completion of last AC dose
Drug: Carboplatin
Area under the concentration curve (AUC) 2 IV once weekly for 9-12 doses beginning two weeks after completion of last AC dose
Drug: GM-CSF
250 μg/mL IV on day 5-14 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide
Drug: Trastuzumab
AUC 2 IV weekly for 12-16 doses beginning two weeks after completion of last AC dose



Primary Outcome Measures :
  1. Clinical Response Rate [ Time Frame: 5 years ]
    Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d'orange.


Secondary Outcome Measures :
  1. Microscopic Pathological Response Rate [ Time Frame: 5 years ]
    pathological response rate: No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

  1. Patients must be women with a histologically confirmed diagnosis of locally advanced or inflammatory breast carcinoma. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.
  2. Patients must meet one of the criteria defined below (indicate one):

    a .Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed appropriate candidates for neoadjuvant treatment.

    b. Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.

  3. Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.
  4. Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible. Patients with hypertension or age > 60 years must have a Multiple Gated Acquisition (MUGA) or echocardiogram scan performed within 90 days prior to registration (indicate not applicable (NA) if no MUGA required) and Left Ventricular Ejection Fraction (LVEF) % must be greater than the institutional lower limit of normal.
  5. Patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of normal, and an Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) ≤ 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.
  6. Patients must have an Absolute neutrophil count (ANC) of ≥ 1,500/μl and a platelet count of ≥ 100,000/μl. These tests must have been performed within 90 days prior to registration.
  7. Patients must have a performance status of 0-2 by Zubrod criteria
  8. Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential.
  9. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256243


Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
Rita Sanghvi, Mehta
Investigators
Principal Investigator: Rita Mehta, MD Chao Family Comprehensive Cancer Center

Responsible Party: Rita Sanghvi, Mehta, Dr. Rita Mehta, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00256243     History of Changes
Other Study ID Numbers: UCI 03-70
2004-3517 ( Other Identifier: University of California, Irvine )
First Posted: November 21, 2005    Key Record Dates
Results First Posted: March 17, 2014
Last Update Posted: March 2, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Doxorubicin
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors