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Compares treatment options for Breast Cancer
Official title Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer
ClinicalTrials.gov ID: NCT05292742
What this study is testing
What is Pyrotinib+Trastuzumab+Capecitabine?
Pyrotinib+Trastuzumab+Capecitabine is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pCR after neoadjuvant therapy
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only. Healthy volunteers may be eligible.
You may be able to join if
- Female patients aged ≥ 18 years and ≤ 75 years old with primary breast cancer
- ECOG score 0 \~ 1
- Breast cancer meets the following criteria: 1）Histologically or pathologically confirmed invasive breast cancer, primary tumor stage determined by...
- Primary breast cancer lesion or lymph node invasive cancer confirmed by pathology after neoadjuvant therapy (residual invasive breast cancer lesion...
- No more than 12 weeks between end of surgery (without post-operative radiotherapy) and randomisation or 6 weeks between end of post-operative...
You likely can't join if
- 1) Stage IV (metastatic) breast cancer;
- 2) inflammatory breast cancer;
- 3) Previous anti-tumor therapy or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell...
- 4) Receiving anti-tumor therapy in other clinical trials, including bisphosphonate therapy or immunotherapy (except radiotherapy and endocrine...
- 5) Receiving any anti-tumor therapy within 28 days before enrollment;
- 6) Peripheral neuropathy ≥ Grade 2 as specified by NCI CTCAE;
See the full eligibility criteria
- Female patients aged ≥ 18 years and ≤ 75 years old with primary breast cancer
- ECOG score 0 \~ 1
- Breast cancer meets the following criteria: 1）Histologically or pathologically confirmed invasive breast cancer, primary tumor stage determined by standard evaluation methods：cT1-4/N0-3/M0. 2）Pathologically confirmed...
- Primary breast cancer lesion or lymph node invasive cancer confirmed by pathology after neoadjuvant therapy (residual invasive breast cancer lesion \> 2 cm or axillary lymph node positive with macrometastasis assessed...
- No more than 12 weeks between end of surgery (without post-operative radiotherapy) and randomisation or 6 weeks between end of post-operative radiotherapy and randomisation
- Required laboratory values including following parameters: ANC: ≥ 1.5 x 109/L Platelet count: ≥ 90 x 109/L Hemoglobin: ≥ 9.0 g/dL Total bilirubin: ≤ 1.5 x upper limit of normal, ULN ALT and AST: ≤ 1.5 x ULN BUN and...
- 1) Stage IV (metastatic) breast cancer;
- 2) inflammatory breast cancer;
- 3) Previous anti-tumor therapy or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma;
- 4) Receiving anti-tumor therapy in other clinical trials, including bisphosphonate therapy or immunotherapy (except radiotherapy and endocrine therapy during treatment);
- 5) Receiving any anti-tumor therapy within 28 days before enrollment;
- 6) Peripheral neuropathy ≥ Grade 2 as specified by NCI CTCAE;
- 7) Receiving pyrrolidone or other anti-HER2 tyrosine kinase inhibitors;
- 8) Receiving anthracycline therapy with cumulative doses as follows: adriamycin \> 240 mg/m2, epirubicin \> 480 mg/m2;
- 9) Receiving major surgery unrelated to breast cancer before randomization, or the patient has not fully recovered from surgery
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.