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Compares treatment options for HER2 Positive Early Breast Cancer
Official title EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer
ClinicalTrials.gov ID: NCT05883852
What this study is testing
What is Docetaxel?
Docetaxel is an investigational medicine, being studied as a potential treatment for her2 positive early 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
- compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 70, women only
You may be able to join if
- Women aged 18-70；
- 0-1 for ECOG；
- Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)；
- No gross or microscopic tumor remains after surgical resection；
- Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive...
You likely can't join if
- Bilateral breast cancer or carcinoma in situ DCIS/LCIS；
- Have received chemotherapy for advanced disease；
- Transfer of any part；
- If any tumor \>T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer)；
- Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy；
- Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy；
See the full eligibility criteria
- Women aged 18-70；
- 0-1 for ECOG；
- Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)；
- No gross or microscopic tumor remains after surgical resection；
- Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive；
- Postoperative pathological stage pT1-4N1-3M0；
- Did not receive neoadjuvant chemotherapy in the past；
- The longest period from surgery to randomization was not more than 8 weeks, and no adjuvant therapy had been received after surgery；
- No peripheral neuropathy；
- Good postoperative recovery, at least 1 week interval between operation；
- The major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥100×109 /L; (2)...
- Contraception during treatment for women of reproductive age；
- Cardiac function: LVEF\>50% for ultrasound examination；
- The people voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up。
- Bilateral breast cancer or carcinoma in situ DCIS/LCIS；
- Have received chemotherapy for advanced disease；
- Transfer of any part；
- If any tumor \>T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer)；
- Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy；
- Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy；
- Malignant neoplasms (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer, within the previous 5 years；
- The patient has been enrolled in other clinical trials；
- Patients with severe systemic disease and/or uncontrolled infection were unable to be enrolled in the study；
- LVEF\<50% (cardiac ultrasound)；
- Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months prior to...
- Known allergy to related drugs；
- Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment；
- Pregnant and lactating women；
- Those who tested positive for pregnancy before taking the drug after joining the trial；
- Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers ；(systematic evaluation is required before trial...
- Persons without personal freedom and independent capacity for civil conduct。
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.