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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Inclusion Criteria:
- 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.)
- 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.
- Documentation of inflammatory breast cancer Inflammatory breast cancer?
- Woman age > or = 18
- Performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) criteria
- Known HER2 status
- 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.
- Date of Echo or multigated acquisition (MUGA) (within 90 days)
- Staging work-up prior to registration
- Date of physical examination (within 90 days)
- Date of bilateral mammogram (within 90 days)
- Date of breast ultrasound (within 30 days)
- Date of MRI breast (within 30 days)
- Chest X-ray (within 90 days)
- Other tests as clinically indicated
- Laboratory requirements:
- Hematology:
- Absolute Neutrophil Count (ANC) ≥ 1,500/μl
- Platelets ≥ 100,000/μl
- Hepatic Function
- Total Bilirubin <1x upper limit of normal (ULN)
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x ULN
- Renal Function
- Creatinine <1. 5x ULN
- Proteinuria
- 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.
- Negative pregnancy test for women of childbearing potential within 14 days prior to
registration.
- 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.
Exclusion Criteria:
- Evidence of distant metastasis
- Known or suspected congestive heart failure, angina pectoris requiring antianginal
medication, or other clinically significant cardiac condition.
- 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.
- Male patients
- Pre-existing peripheral neuropathy of severity grade ≥ 2 (limiting instrumental
activities of daily living).
- Incomplete wound healing.
- Active and significant bleeding
- Known allergy, hypersensitivity or prior infusion reaction to one or more of the
therapies incorporated into this treatment protocol.
- Bone marrow depression or hematologic parameters in the range that would increase the
risk for severe bleeding.
Exclusion criteria for participating in MRI monitoring sub-study: Subjects will not be
eligible to participate in the MRI response monitoring sub-study, if they have:
- Implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical
clips (hemostatic clips) or other metallic implants.
- Engaged in occupations or activities which may cause accidental lodging of
ferromagnetic materials, or have imbedded metal fragments from military activities.
- Received orthodontic work involving ferromagnetic materials.
- Claustrophobia (a fear of enclosed spaces).
- Previously had an allergic response to MR contrast agents (gadolinium).
- Known history of severe renal insufficiency, asthma, allergic conditions, sickle cell
anemia, chronic hemolytic anemia, and gastrointestinal disorders.
UC Irvine Health Chao Family Comprehensive Cancer Center, Phone: 1-877-UC-STUDY, Email: UCstudy@uci.edu