Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer

NCT02827877 | Active Not Recruiting Phase 2 Results DMC

• 2 other identifiers: 16079FWA 00000692
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as copper Cu 64 DOTA-trastuzumab PET, may help predict a patient's response to trastuzumab and pertuzumab before surgery in patients with locally advanced HER2 positive breast cancer.

Conditions

HER2 Positive Breast Carcinoma; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy).

  The response assessment is performed at the time of definitive surgery. Patients' disease will be staged in the conventional manner according to the AJCC. The primary endpoint is complete pathologic response defined as no evidence of residual invasive cancer in either the breast or regional lymph nodes.

  Up to 1 year

Other Outcomes (1)

• SUV Measurement by 64Cu-DOTA Trastuzumab PET

  Baseline

Study Arms (1)

Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)

EXPERIMENTAL

Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab.

Radiation: Copper Cu 64-DOTA-Trastuzumab; Other: Laboratory Biomarker Analysis; Biological: Pertuzumab; Procedure: Positron Emission Tomography; Procedure: Therapeutic Conventional Surgery; Biological: Trastuzumab

Interventions

Copper Cu 64-DOTA-Trastuzumab RADIATION

Given IV

Also known as: 64Cu-DOTA-Trastuzumab

Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)

Pertuzumab BIOLOGICAL

Given IV

Also known as: 2C4, 2C4 Antibody, MoAb 2C4, Monoclonal Antibody 2C4, Perjeta, rhuMAb2C4, RO4368451

Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)

Positron Emission Tomography PROCEDURE

Undergo PET

Also known as: PET Scan

Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery

Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)

Trastuzumab BIOLOGICAL

Given IV

Also known as: ABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, c-erb-2 Monoclonal Antibody, HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, MoAb HER2, Monoclonal Antibody c-erb-2, Monoclonal Antibody HER2, PF-05280014, rhuMAb HER2, RO0452317, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar PF-05280014

Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be women who have histological confirmation of HER2 positive breast cancer
• The primary tumor must be \>= 2.0cm in size and/or have biopsy proven axillary nodes that are \>= 2.0cm in size by mammography, ultrasound, or magnetic resonance imaging (MRI)
• The current cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
• Patients may not have received prior HER2 directed therapies
• Participants must have normal cardiac ejection fraction (per label, as defined as institutional normal)
• Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and chemotherapy
• Ability to provide informed consent
• Negative Serum Pregnancy test

You may not qualify if:

• Participants who are not considered candidates for pertuzumab + trastuzumab + chemotherapy
• Concurrent malignancy other than non-melanoma skin cancer
• Patients must not have known metastatic disease
• Patients must not have received prior treatment for the current breast cancer

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

64Cu-DOTA-trastuzumab; pertuzumab; 2C4 antibody; Magnetic Resonance Spectroscopy; Trastuzumab; PF-05280014

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Joanne Mortimer
• Organization: City of Hope Medical Center

jmortimer@coh.org

626-359-8111

Study Officials

• Joanne Mortimer

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: July 11, 2016
• Study Start: July 15, 2016
• Primary Completion: July 2, 2020
• Study Completion (Estimated): September 25, 2026
• Last Updated: November 14, 2025
• Results First Posted: March 9, 2023

Record last verified: 2025-11

Locations

US (1)