PET Scan Predictors for HER2+ Breast Cancer Treatment Response

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must be taking: Trastuzumab, Pertuzumab

Disqualifiers: Metastatic disease, Concurrent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

18 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves specific cancer treatments, it's best to discuss your current medications with the trial team to ensure there are no conflicts.

What data supports the effectiveness of the drug Copper Cu 64-DOTA-Trastuzumab, Pertuzumab, Perjeta, Trastuzumab, Herceptin, Trazimera, Herzuma, Ontruzant for HER2+ breast cancer treatment?

Research shows that PET scans can help predict how well patients with HER2-positive breast cancer will respond to treatments like trastuzumab and pertuzumab. These drugs have been effective in targeting HER2, a protein that promotes cancer growth, and PET scans can help identify patients who are likely to benefit from these therapies. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Pertuzumab and trastuzumab, used in treating HER2-positive breast cancer, have been associated with improved patient outcomes in clinical trials, suggesting they are generally safe when used as directed. ^{1 5 6 7 8}

What makes the drug Pertuzumab and Trastuzumab unique for treating HER2+ breast cancer?

This drug combination is unique because it uses PET scans to predict how well a patient will respond to the treatment, allowing for more personalized therapy. It targets the HER2 protein on cancer cells, which is a specific marker for this type of breast cancer, and the use of PET scans helps in assessing the effectiveness early on. ^{1 2 5 9 10}

What is the purpose of this trial?

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.

Research Team

Joanne Mortimer

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for women with HER2 positive breast cancer that's locally advanced. They must have a tumor at least 2cm big or similarly sized lymph nodes, confirmed by imaging tests. Participants need normal heart function and haven't had prior HER2 treatments. Pregnant women can't join, nor those who've received treatment for the current cancer or have another active cancer.

Inclusion Criteria

My primary tumor or lymph nodes are at least 2cm large as confirmed by imaging.

I am a woman with lab-confirmed HER2 positive breast cancer.

I have not had treatments specifically targeting HER2.

Exclusion Criteria

I am not a candidate for the standard HER2 cancer treatment.

My cancer has not spread to distant parts of my body.

I have cancer other than non-melanoma skin cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging and Initial Treatment

Patients receive trastuzumab and copper Cu 64-DOTA-trastuzumab followed by PET scans to predict treatment response

1 week

2 visits (in-person)

Neoadjuvant Treatment

Patients receive trastuzumab and pertuzumab every 21 days for 6 cycles

18 weeks

6 visits (in-person)

Surgery

Patients undergo surgery after completion of neoadjuvant treatment

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Copper Cu 64-DOTA-Trastuzumab
• Pertuzumab
• Trastuzumab

Trial Overview The study is testing if a PET scan using Cu64-DOTA-trastuzumab can predict how well patients respond to pre-surgery treatment with trastuzumab and pertuzumab. It involves diagnostic procedures before receiving six cycles of combined therapy with these drugs plus chemotherapy.

Participant Groups

Group I: Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET) Experimental Treatment 6 Interventions

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.

Pertuzumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Perjeta for:

• Early breast cancer
• Metastatic breast cancer

Approved in United States as Perjeta for:

• Early breast cancer
• Metastatic breast cancer

Approved in Canada as Perjeta for:

• Early breast cancer
• Metastatic breast cancer

Approved in Japan as Perjeta for:

• Early breast cancer
• Metastatic breast cancer

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Pertuzumab, a new monoclonal antibody targeting HER2, has shown improved patient outcomes in clinical trials for early-stage and metastatic HER2-positive breast cancer, especially when used in combination with chemotherapy and trastuzumab.

The review highlights that while trastuzumab has improved survival for HER2-positive breast cancer, there is still a need for better treatment options, which pertuzumab aims to address, particularly for patients who continue to relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pertuzumab in human epidermal growth-factor receptor 2-positive breast cancer: clinical and economic considerations. Lamond, NW., Younis, T.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathologic Complete Response to Pertuzumab and Trastuzumab in Breast Cancer. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Imaging Diagnostic and Therapeutic Targets: Human Epidermal Growth Factor Receptor 2. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Pretreatment 18F-FDG uptake heterogeneity may predict treatment outcome of combined Trastuzumab and Pertuzumab therapy in patients with metastatic HER2 positive breast cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Molecular imaging as biomarker for treatment response and outcome in breast cancer. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Updated Results of TBCRC026: Phase II Trial Correlating Standardized Uptake Value With Pathological Complete Response to Pertuzumab and Trastuzumab in Breast Cancer. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Pertuzumab in human epidermal growth-factor receptor 2-positive breast cancer: clinical and economic considerations. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Identification of HER2-Positive Metastases in Patients with HER2-Negative Primary Breast Cancer by Using HER2-targeted 89Zr-Pertuzumab PET/CT. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Micro-SPECT/CT with 111In-DTPA-pertuzumab sensitively detects trastuzumab-mediated HER2 downregulation and tumor response in athymic mice bearing MDA-MB-361 human breast cancer xenografts. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Long-term outcomes in patients with PET-predicted poor-responsive HER2-positive breast cancer treated with neoadjuvant bevacizumab added to trastuzumab and docetaxel: 5-year follow-up of the randomised Avataxher study. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

The influence of receptor expression and clinical subtypes on baseline [18F]FDG uptake in breast cancer: systematic review and meta-analysis. [2023]