Breast Cancer
Conditions
Brief summary
This is a prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive breast cancer.
Detailed description
Patients with early-stage or locally advanced HER2-positive breast cancer were planned to be enrolled and subjected to neoadjuvant therapy with the regimen of Trastuzumab Rezetecan combined with Pertuzumab. The primary objective was to evaluate the efficacy and safety of Trastuzumab Rezetecan plus Pertuzumab as neoadjuvant treatment for early-stage or locally advanced HER2-positive breast cancer. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.
Interventions
Trastuzumab Rezetecan
DRUGPertuzumab
Pertuzumab
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients aged 18-70 years; 2. Histopathologically confirmed HER2 positive breast cancer; 3. Patients were diagnosed with stage II-III breast cancer; 4. At least one measurable target lesion according to RECIST V1.1; 5. ECOG performance status score of 0 to 1; 6. Life expectancy ≥12 weeks; 7. Adequate bone marrow reserve and organ system function reserve; 8. Participants should be able and willing to comply with the study protocol requirement;
Exclusion criteria
1. Breast cancer not histologically confirmed; 2. Known inherited or acquired bleeding and thrombotic tendencies; 3. Known allergy or contraindication to the study drug and its excipients; 4. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); 5. Concurrent receipt of any other form of anti-cancer therapy; 6. History of a second primary malignancy, except for adequately treated skin cancer; 7. Participation in other drug clinical trials within 4 weeks before enrollment; 8. Major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures; 9. Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence; 10. Uncontrolled or significant cardiovascular and cerebrovascular diseases; 11. Subjects with known or suspected interstitial pneumonia; 12. Presence of active hepatitis B, hepatitis C, liver cirrhosis; 13. Pregnant or lactating female patients; 14. History of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR rate | At the time of surgery | Total pathological complete response (tpCR: ypT0-is，ypN0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| iDFS | Up to approximately 5 years | Invasive disease-free survival |
| EFS | Up to approximately 5 years | Event-free survival |
| ORR | Up to approximately 24 weeks after the first administration | Objective Response Rate |
| AEs | From the first dose until 30 days after last dose | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to CTCAE 5.0 |
Contacts
Primary ContactZhenzhen Liu
Outcome results
None listed