Breast Cancer Clinical Trial
Official title:
A Multicenter Phase II Clinical Study of Pyrotinib or Pertuzumab Combined With Docetaxel, Carboplatin, and Trastuzumab in Neoadjuvant Therapy for HR-positive, HER2-positive Breast Cancer
Due to neoadjuvant therapy with trastuzumab and pertuzumab is less effective for HR+/HER2+ breast cancer, and the PHEDRA Clinical Study subgroup analysis showed that the addition of pyrotinib to trastuzumab more than doubled pCR rates in HR+/HER2+ patients. our research group proposed a hypothesis that pyrotinib may be more advantageous for HR+/HER2+ breast cancer. Therefore, our center intends to carry out a multi-center, randomized controlled, prospective clinical study to compare the efficacy of pyrotinib or pertuzumab combined with docetaxel, carboplatin and trastuzumab in neoadjuvant therapy for patients with HR+/HER2+ breast cancer, and to conduct a comparative study on the safety.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | September 30, 2025 |
Est. primary completion date | June 15, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Women aged 18-70 with breast cancer; 2. Pathologically confirmed unilateral invasive ductal carcinoma (with or without intraductal carcinoma components); 3. Proposed to receive neoadjuvant therapy; 4. Positive ER and/or PgR (defined as =10% positive immunohistochemical test); 5. HER2 positive (defined as IMMUNOHISTOchemical HER2 ++, or HER2 ++ and in situ hybridization (ISH) results in HER2 gene amplification); 6. There is no evidence of metastasis in clinical or imaging; 7. ECOG score 0 or 1; 8. White blood cell count =3.5×109/L, neutrophil count =2×109/L, platelet count =100×109/L and hemoglobin =90 g/L before neoadjuvant therapy; 9. Before neoadjuvant therapy, AST and ALT < 1.5 times the upper limit of normal value, alkaline phosphatase < 2.5 times the upper limit of normal value, total bilirubin < 1.5 times the upper limit of normal value; Serum creatinine < 1.5 times the upper limit of normal value; 10. LVEF=55% on 2d echocardiography before neoadjuvant therapy; 11. Signed informed consent. Exclusion Criteria: 1. Clinical or imaging suspicion of lateral breast malignancy has not been confirmed; 2. Prior malignancy (except basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer; 3. The patient has been enrolled in other clinical trials; 4. Patients suffering from serious systemic diseases and/or uncontrollable infections cannot be enrolled in the study; 5. Severe cardiovascular and cerebrovascular diseases (e.g., unstable angina pectoris, chronic heart failure, uncontrolled hypertension > 150/90mmHg, myocardial infarction or cerebrovascular accident) within the first 6 months of randomization; 6. Have a history of blood system diseases, especially platelet-related diseases; 7. Patients with previous intestinal inflammation, intestinal dysfunction, severe diarrhea and constipation; 8. People who are known to be allergic to chemotherapy drugs, targeted drugs or TKI drugs; 9. Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment; 10. Pregnant and lactation women; 11. positive pregnancy test before drug use after joining the test; 12. Mental illness, cognitive impairment, inability to understand the test protocol and side effects, inability to complete the test protocol and follow-up workers (systematic evaluation is required before the trial is enrolled); 13. Persons without personal freedom and independent capacity for civil conduct. |
Country | Name | City | State |
---|---|---|---|
China | the First Affiliated Hospital of Nanjing Medical University | Nanjing |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | tpCR rate (ypT0/is ypN0) | Pathological complete response rate after neoadjuvant ( both breast and axillary lymph nodes, in which the breast may have residual carcinoma in situ) | 1 month after surgery | |
Secondary | iDFS | invasive Disease Free Survival | 3 years | |
Secondary | EFS | Event Free Survival | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |