Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
estimated completion
Principal Investigator
Rita Mehta, MD

Description

Summary

The purpose of this phase II is to study the efficacy and toxicity of carboplatin and paclitaxel with pertuzumab and trastuzumab in HER2 positive and carboplatin and paclitaxel with bevacizumab in HER2 negative in the neoadjuvant setting for the treatment of breast cancer.

Official Title

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting

Details

OBJECTIVES The study component is to evaluate the treatment response and toxicity of the protocol.

Objectives for treatment study component:

1.1 To estimate 2-year progression-free survival in patients with breast cancer with tumor more than 1 cm and/or with clinically detected lymph node treated with neoadjuvant weekly Carboplatin and Paclitaxel combined with Trastuzumab + Pertuzumab in HER2-positive disease or with Bevacizumab in HER2-negative disease.

1.2 To measure the microscopic complete pathological response (pCR) rates defined as ypT0 or ypTis tumors in patients treated with this regimen in the neoadjuvant setting.

1.3 To assess complete clinical response (cCR) rates after treatment by physical exam and imaging tests (ultrasonography, mammography, or magnetic resonance imaging) clinical objective response rate (by Response Evaluation Criteria In Solid Tumors (RECIST)) 1.4 To determine the toxicity of this regimen. 1.5 To determine treatment adherence and delivered dose intensity of this regimen.

1.6 To assess the correlation between pCR and cCR. 1.7 To determine the rate of breast conservation following neoadjuvant therapy. 1.8 Determine treatment efficacy according to subgroups defined according to stage and receptor status.

Keywords

Breast Carcinoma Neoadjuvant Treatment Carboplatin Paclitaxel Pertuzumab Trastuzumab Bevacizumab Breast Neoplasms Carboplatin+Paclitaxel+Bevacizumab (HER2-) Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)

Eligibility

You can join if…

Open to females ages 18 years and up

  1. Histologically proven unilateral or bilateral primary breast carcinoma. (In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint.)
  2. Tumor size is clinically at least 1 cm in greatest diameter (palpable or by imaging) and/or with involved lymph node. In case of inflammatory disease, the extent of inflammation may be the measurable lesion.
  3. Documentation of inflammatory breast cancer
  4. Woman age > or = 18
  5. Performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) criteria
  6. Known HER2 status
  7. Normal cardiac function must be documented within 90 days prior to registration. Result of ejection fraction must be above the normal limit of the institution. Echo or MUGA is encouraged pre-study.
  8. Date of Echo or multigated acquisition (MUGA) (within 90 days)
  9. Staging work-up prior to registration
  10. Date of physical examination (within 90 days)
  11. Date of bilateral mammogram (within 90 days)
  12. Date of breast ultrasound (within 90 days)
  13. Date of MRI breast (within 30 days)
  14. Chest X-ray or CT-Chest or CT/PET Scan that includes the Chest is also accepted (within 90 days)
  15. Other tests as clinically indicated
  16. Laboratory requirements:
  17. Hematology:
  18. Absolute Neutrophil Count (ANC) ≥ 1,500/μl
  19. Platelets ≥ 100,000/μl
  20. Hepatic Function
  21. Total Bilirubin <1x upper limit of normal (ULN)
  22. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x ULN
  23. Renal Function
  24. Creatinine <1.5x ULN
  25. Proteinuria
  26. Urine dipstick for proteinuria <2+. Patients discovered to have ≥2+ proteinuria on dipstick should undergo a 24-hour urine collection and demonstrate ≤ 1g of protein in 24 hours.
  27. Negative pregnancy test for women of childbearing potential within 14 days prior to registration.
  28. . 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.

You CAN'T join if...

  1. . Evidence of distant metastasis
  2. . Known or suspected congestive heart failure, angina pectoris requiring antianginal medication, or other clinically significant cardiac condition.
  3. . Pregnant or nursing women may not participate due to the possibility of harm to fetus or nursing infants from this treatment regimen. Women of childbearing potential may not participate unless they have agreed to use an adequate contraceptive method throughout study treatment and for one month after completion of treatment.
  4. . Male patients
  5. . Pre-existing peripheral neuropathy of severity grade ≥ 2 (limiting instrumental activities of daily living).
  6. . Incomplete wound healing.
  7. . Active and significant bleeding
  8. . Known allergy, hypersensitivity or prior infusion reaction to one or more of the therapies incorporated into this treatment protocol.
  9. . Bone marrow depression or hematologic parameters in the range that would increase the risk for severe bleeding.

Location

  • UC Irvine Health/Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Rita Mehta, MD
    Health Sciences Professor, Medicine. Authored (or co-authored) 97 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT02436993
Phase
Phase 2
Study Type
Interventional
Last Updated