Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab

NCT02436993 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 20151888UCI 14-67
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Carcinoma

Keywords

Neoadjuvant Treatment; Carboplatin; Paclitaxel; Pertuzumab; Trastuzumab; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• 2-year progression free survival in patients treated with weekly carboplatin and paclitaxel combined with either trastuzumab and pertuzumab for HER2-positive patients or bevacizumab for HER2-negative patients in the neoadjuvant setting

  Progression of disease-A new lesion or a greater than or equal to 25% increase in the product of the largest perpendicular diameters of any one lesion on clinical exam or by U/S or MRI Survival-from date of registration to date of death

  2 years

Secondary Outcomes (4)

• Clinical complete response rates

  2 years

• Pathologic complete response rates

  2 years

• Number of toxicities in Carboplatin+Paclitaxel+Bevacizumab (HER2) arm

  Up to 42 days after discontinued treatment

• Number of toxicities in Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)

  Up to 42 days after discontinued treatment

Study Arms (2)

Carboplatin+Paclitaxel+Bevacizumab (HER2-)

EXPERIMENTAL

Carboplatin weekly 12 doses Paclitaxel weekly 12 doses Bevacizumab every other week, 5 doses

Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab

Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)

EXPERIMENTAL

Carboplatin weekly 12 doses Paclitaxel weekly 12 doses Trastuzumab weekly 12 doses Pertuzumab every 3 weeks, 4 doses

Drug: Carboplatin; Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab

Interventions

Carboplatin DRUG

Area Under the Curve (AUC) 2 IV over 60 minutes weekly for 12 doses

Also known as: Paraplatin

Carboplatin+Paclitaxel+Bevacizumab (HER2-); Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)

Paclitaxel DRUG

80 mg/m\^2 IV over 1-3 hours weekly for 12 doses

Also known as: Taxol

Carboplatin+Paclitaxel+Bevacizumab (HER2-); Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)

Bevacizumab DRUG

10mg/kg IV over 90 or 60 or 30 minutes every other week for 5 doses

Also known as: Avastin

Carboplatin+Paclitaxel+Bevacizumab (HER2-)

Trastuzumab DRUG

4mg/kg induction, followed by weekly 2mg/kg IV-induction over 90 minutes, then weekly over 30-60 minutes for 12 doses

Also known as: Herceptin

Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)

Pertuzumab DRUG

840mg induction, followed by 420mg every 3 weeks IV-induction over 60 minutes, then every 3 weeks over 30-60 minutes for 4 doses

Also known as: Perjeta

Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 either via an ECHO or MUGA or per physician's review of symptoms and medical history. If an ECHO is performed as standard of care, the ejection fraction must be above the normal limit of the institution.. If not available in the medical chart, the ECHOs or MUGAs are not required to be repeated for research purposes.
• a. Date of Echo or multigated acquisition (MUGA) (within 90 days) if performed
• 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 90 days)
• Date of MRI breast (within 30 days)
• Chest X-ray or CT- Chest or CT/PET Scan that includes the Chest may be done at physician's discretion (within 90 days). If not available in the medical chart, the Chest X-ray or CT- Chest or CT/PET Scan that includes the Chest is not required to be repeated for research purposes.
• Other tests as clinically indicated

You may not qualify if:

• Evidence of distant metastasis. If radiographic suspicion of distant metastatic site, a negative biopsy must be available in the medical record. If not available in the medical record, the subject may be included and a confirmatory biopsy is not required to be performed for research purposes.
• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Carboplatin; Paclitaxel; Bevacizumab; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rita Mehta, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HS Clinical Professor

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 7, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2023
• Study Completion (Estimated): December 1, 2036
• Last Updated: July 14, 2025

Record last verified: 2024-12

Locations

US (1)