Neoadjuvant Treatment of Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of California, Irvine.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of California, Irvine
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00254592
First received: November 15, 2005
Last updated: February 7, 2008
Last verified: February 2008
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Purpose
Study Aims
- To measure the clinic response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2-4 cycles of biweekly doxorubicin, cyclophosphamide with GM-CSF (days 5-14) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks).
- To measure the microscopic pathological response rate of this regimen.
- To measure toxicity and the delivered dose intensity of this regimen.
- To assess the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients.
- To determine whether the GM-CSF increases the post treatment dendritic cells (S100+) percentage in the tumor draining lymph node as compared to pretreatment S100+ cells.
- To determine whether the patients with a higher percent S100+ have a better clinical, pathological response, DFS, and OS.
- To determine whether flow cytometry of dendritic cells performed post-treatment in blood sample shows an increase in dendritic cell population compared to pretreatment levels.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Doxorubicin Drug: Cyclophosphamide Drug: Carboplatin Drug: Nab-paclitaxel Drug: GM-CSF Drug: Trastuzumab Drug: Bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide With GMCSF Followed by Weekly Carboplatin/Nab-Paclitaxel Plus or Minus Trastuzumab (Herceptin) and Plus or Minus Bevacizumab (Avastin) in Treatment of Large or Inflammatory Breast Cancer-a Phase II Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Doxorubicin
Doxorubicin hydrochloride
Paclitaxel
Carboplatin
Sargramostim
Trastuzumab
Bevacizumab
U.S. FDA Resources
Further study details as provided by University of California, Irvine:
Primary Outcome Measures:
- Overall clinical response to the dose dense regimen. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 43 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Doxorubicin
- Adriamycin
- NSC-123127
- Cytoxan
- NSC-26271
- Paraplatin
- NSC 241240
- Albumin-stabilized nanoparticle formulation of paclitaxel
- Abraxane
- ABI 007
- Sargramostim
- Leukine
- Berlex
- NSC-613795
60 mg/m2 IV, bolus once a day every 14 days x 2-4 cycles
Other Names:
Drug: Cyclophosphamide
600 mg/m2 IV once a day every 14 days x 2-4 cycles
Other Names:
Drug: Carboplatin
AUC 2 IV weekly for 9-12 doses beginning two weeks after completion of last AC dose
Other Names:
Drug: Nab-paclitaxel
100 mg/m2 IV over 30 min weekly for 9-12 doses beginning two weeks after completion of last AC dose
Other Names:
Drug: GM-CSF
250 μg/mL IV or on day 4-13 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide
Other Names:
Drug: Trastuzumab
4mg/kg, and then2 mg/kg q wk IV weekly for 12-16 doses beginning two weeks after completion of last AC dose
Drug: Bevacizumab
10mg/kg q 2 wks
Other Name: Avastin
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 must be women with a histologically confirmed diagnosis of breast cancer that is more than 2 cm and/or lymph node positive. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.
Patients must meet one of the criteria defined below (indicate one):
- 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.
- Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.
- Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.
- Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible. All patients must have a MUGA or echocardiogram scan performed within 90 days prior to registration and LVEF% must be greater than the institutional lower limit of normal.
- Patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of normal, and an SGOT or SGPT ≤ 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.
- Patients must have an 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.
- Patients must have a performance status of 0-2 by Zubrod criteria
- 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.
- In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254592
Locations
| United States, California | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
Sponsors and Collaborators
University of California, Irvine
Investigators
| Principal Investigator: | Rita Mehta, M.D. | Chao Family Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | Rita Mehta, M.D., University of California, Irvine Medical Center |
| ClinicalTrials.gov Identifier: | NCT00254592 History of Changes |
| Other Study ID Numbers: | UCI 05-38 |
| Study First Received: | November 15, 2005 |
| Last Updated: | February 7, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Inflammatory Breast Cancer Female |
Neo-adjuvant HER2 positive Hormone receptor |
Additional relevant MeSH terms:
|
Breast Neoplasms Inflammatory Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Trastuzumab Bevacizumab Doxorubicin Carboplatin 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 Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Angiogenesis Modulating Agents |
ClinicalTrials.gov processed this record on May 19, 2013