Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Copper (Cu) 64-DOTA-Trastuzumab PET Imaging in Predicting Response to Treatment With Trastuzumab and Pertuzumab Before Surgery in Patients With HER2 Positive Breast Cancer

Summary: This pilot clinical 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.

Detailed description: PRIMARY OBJECTIVES:
  I. To evaluate the standardized uptake value maximum (SUVmax) in patients with previously untreated HER2+ breast cancer.
  SECONDARY OBJECTIVES:
  I. To evaluate if the uptake of copper 64 Cu-64-DOTA-trastuzumab, a proposed indicator of responsiveness to HER2-directed therapy, correlates with serpin peptidase inhibitor alpha-1 antiproteinase, antitrypsin, member 1 gene (SERPINA1) expression, which has been shown to be associated with estrogen receptor positive (ER+)/ HER2+ patient survival, both in the HER2+/ER+ patients and in all patients.
  II. To compare uptake of copper Cu 64-DOTA-trastuzumab in the patients with complete pathologic response (pCR) vs. non-pCR patients.
  OUTLINE:
  Patients receive trastuzumab intravenously (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 2. Within 3 days after completion of PET scans, patients then 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 courses in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 courses of trastuzumab and pertuzumab.
  After completion of study treatment, patients are followed up for 1 year.

Eligibility: Inclusion Criteria:
  -  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) 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
  Exclusion Criteria:
  -  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
  -  Inability to provide informed consent

Relevance to patient case: not relevant