Evaluating a new treatment approach for operable HER2-positive breast cancer

Gene Expression Assays and 68 Ga-Affibody HER-2 Imaging PET in Predicting Response to Treatment With Trastuzumab and Pertuzumab Before Surgery in Chinese Patients With HER2 Positive Breast Cancer

This study is testing a new combination of medications and chemotherapy before surgery to see if it helps people with HER2-positive breast cancer achieve better treatment results.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, pertuzumab, trastuzumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04281641 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of a pre-operative treatment regimen combining pertuzumab and trastuzumab with chemotherapy in patients with HER2-positive breast cancer. It will investigate the correlation between early changes in various biomarkers and the likelihood of achieving a pathological complete response (pCR) after treatment. The study will utilize advanced imaging techniques and genomic testing to evaluate treatment response in approximately 94 patients. Participants will receive the treatment followed by surgery and continue with a year of adjuvant therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with operable HER2-positive breast cancer and a primary tumor larger than 2 cm.

Not a fit: Patients with previously treated invasive malignancies or those with a left ventricular ejection fraction below 55% may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective pre-operative treatments for patients with HER2-positive breast cancer, potentially improving surgical outcomes.

How similar studies have performed: Other studies have shown promising results with similar neoadjuvant therapies for HER2-positive breast cancer, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Female or male, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
2. Primary tumor greater than (\>) 2 cm in diameter.
3. Age ≥ 18 years and \< 70 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1.
5. Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55%
6. Availability of tumor tissue specimen after surgery.
7. Participants agree to undergo a core needle biopsy for genomic testing and organoid drug sensitivity assay.
8. Histologically proven diagnosis of breast cancer.
9. Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH).
10. Had hormonal receptors (ER and PgR) assessed.
11. Signed informed consent.
12. Able to comply with the protocol.

Exclusion Criteria:

1. Metastatic disease (Stage IV) or bilateral breast cancer.
2. Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer.
3. Prior breast or non-breast malignancy within 5 years prior to study entry.
4. Inadequate bone marrow, renal, or liver function
5. History or evidence of cardiovascular condition
6. Severe, uncontrolled systemic disease
7. Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications.
8. Pregnancy or breast-feeding women.
9. Participants who received any investigational treatment within 4 weeks of study start.
10. Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
11. Current chronic daily treatment with corticosteroids (dose \>10 mg methylprednisolone or equivalent \[excluding inhaled steroids\]).
12. Known hypersensitivity to any of the study drugs or excipients

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Cancer Center, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jiong Wu, MD

Conditions: HER2-positive Breast Cancer