Clinical trial NCT04094896: TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer
Official title: TCHP (Docetaxel/Carboplatin/Trastuzumab/Pertuzumab) Versus EC -THP(Epirubicin/ Cyclophosphamide Followed by Docetaxe/Trastuzumab/Pertuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HER2-Positive Breast Cancer
Keywords: Neoadjuvant Treatment
HER2-Positive Breast Cancer
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment in HER2- Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.

Detailed description: Both TCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment in HER2- Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.

Eligibility criteria: Inclusion Criteria:

* • Histologically or cytologically confirmed HER2 positive invasive breast carcinoma

  * Clinical stage #-#B
  * Patients must have measurable disease as defined by palpable lesion with both diameters ≥2cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension ≥2cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, xrays and scans must be done within 28 days of study entry.
  * Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
  * Normal (greater than 50%) left ventricular ejection fraction (LVEF) by echocardiography
  * Signed informed consent
  * Adequate organ function within 2 weeks of study entry:

Absolute neutrophil count \>1500/mm3, Hgb \>9.0 g/dl and platelet count \>100,000/mm3 Total bilirubin \< upper limit of normal Creatinine \< 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) \>50mL/min using the Cockcroft Gault equation serum glutamate oxaloacetate transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline Phosphatase must be within the range allowing for eligibility

* Patients must be over 18 years old.
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
* Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.

Exclusion Criteria:

* • Metastatic disease

  * Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone.
  * History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.

Primary outcomes:
measure: pCR
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
Study officials:
References: