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Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2 Positive Operable Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial

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ClinicalTrials.gov Identifier: NCT04547907
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Liuzhenzhen, Henan Cancer Hospital

Study Description
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Brief Summary:
At present, trastuzumab combined with patuzumab has become the standard neoadjuvant therapy for high-risk HER2 positive breast cancer. TCbHP has been the standard choice of neoadjuvant therapy for HER2 positive breast cancer patients with early high-risk or locally advanced HER2 positive breast cancer. Whether nab-PHP can achieve the same effect as TCbHP is still uncertain.

Condition or disease Intervention/treatment Phase
Breast Cancer,Her2 Positive Drug: Albumin binding paclitaxel+ trastuzumab+ patuzumab Drug: Docetaxel+ carboplatin+ trastuzumab + patuzumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing the Efficacy of Nab-PHP(Albumin Bound Paclitaxel + Trastuzumab + Patuzumab) and TCbHP(Docetaxel + Carboplatin + Trastuzumab + Patuzumab) in Neoadjuvant Chemotherapy for HER2 Positive Operable Breast Cancer , A Multicenter, Randomized, Phase III Clinical Trial
Actual Study Start Date : September 18, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: nab-PHP
Albumin binding paclitaxel + trastuzumab+ patuzumab
 Drug: Albumin binding paclitaxel+ trastuzumab+ patuzumab
Albumin binding paclitaxel 125 mg / m2 (1, 8, 15 days) + trastuzumab (8 mg / kg for the first loading dose and 6 mg / kg for the sequential maintenance dose) + patuzumab (840mg for the first loading dose and 420mg for the sequential maintenance dose) ，every 21 days for 6 cycles.
Active Comparator: TCbHP
Docetaxel + carboplatin + trastuzumab + patuzumab
 Drug: Docetaxel+ carboplatin+ trastuzumab + patuzumab
Docetaxel 75 mg/m2 + carboplatin (AUC = 6) + trastuzumab(8 mg / kg for the first loading dose and 6 mg / kg for the sequential maintenance dose) + patuzumab (840mg for the first loading dose and 420mg for the sequential maintenance dose) ，every 21 days for 6 cycles.


Outcome Measures
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Primary Outcome Measures :
  1. Pathological Complete Response (pCR) [ Time Frame: through study completion, an average of 1 year ]
    Percentage of Participants With Pathological Complete Response (pCR) (ypT0/is/N0M0) after 6 cycles of neoadjuvant chemotherapy


Secondary Outcome Measures :
  1. ORR [ Time Frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months ]
    Objective Response Rate

  2. DFS [ Time Frame: Following surgery until Year 5 ]
    Disease-free Survival

  3. OS [ Time Frame: Following surgery until Year 5 ]
    Overall Survival


Other Outcome Measures:
  1. Incidence and severity of adverse events [ Time Frame: through study completion, an average of 1 year ]
    Incidence and severity of adverse events classified by NCI CTCAE4.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years ≤ age ≤ 75 years, Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
  2. Clinical T2-T4d, or T1c with axillary LN+
  3. HER2 + invasive breast cancer confirmed by histopathology Note: HER2 expression positive refers to the tumor cells with immunohistochemical staining intensity of 3 + or confirmed positive by fluorescence in situ hybridization [fish] at least once during the pathological detection/review of primary tumor in the Department of pathology of participating research center hospital
  4. Clinically measurable lesions: measurable lesions revealed by ultrasound, molybdenum target or MR (optional) within 1 month before randomization

  5. Organ and bone marrow function test within one month before chemotherapy showed no chemotherapy contraindication

    • Absolute value of neutrophil count ≥ 2.0×10^9 / L
    • Hemoglobin ≥ 100g / L
    • Platelet count ≥ 100×10^9 / L
    • Total bilirubin < 1.5 ULN (upper limit of normal value)
    • Creatinine < 1.5 × ULN
    • AST/ALT < 1.5×ULN
  6. Echocardiography: left ventricular ejection fraction (LVEF ≥ 55%)
  7. For women of childbearing age, serum pregnancy test was negative 14 days before randomization
  8. KPS score ≥ 80 points
  9. Signed the informed consent form prior to patient entry

Exclusion Criteria:

  1. Metastatic disease (Stage IV)
  2. Chemotherapy, endocrine therapy, targeted therapy and reflexotherapy have been used for this disease
  3. The patient had a second primary malignant tumor, except for the well treated skin cancer
  4. Patients who had undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or had not recovered completely from such operations

  5. Serious heart disease or discomfort, including but not limited to the following diseases:

    • History of heart failure or systolic dysfunction (LVEF < 50%)
    • high risk uncontrolled arrhythmias such as atrial tachycardia, resting heart rate > 100 BPM, significant ventricular arrhythmias (e.g., ventricular tachycardia) or higher-level atrioventricular block (i.e., mobitz II second degree atrioventricular block or third degree atrioventricular block)
    • angina pectoris requiring anti angina drugs
    • Heart valve disease with clinical significance
    • ECG showed transmural myocardial infarction
    • Poor control of hypertension (systolic blood pressure > 180 mmHg and / or diastolic blood pressure > 100 mmHg)
  6. Due to serious and uncontrollable other medical diseases, the researchers believe that there are chemotherapy contraindications
  7. Those who have been known to have allergic history to the drug components of this regimen; have a history of immune deficiency, including HIV positive test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547907


Contacts
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Contact: Zhenzhen Liu 13603862755 liuzhenzhen73@163.com
Contact: Jiujun Zhu 13676962766 bigapple0601@126.com

Locations
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China, Henan
Henan cancer hospital Recruiting
Zhengzhou, Henan, China
Contact: Zhenzhen Liu    17729798130    liuzhenzhen73@126.com   
Sponsors and Collaborators
Henan Cancer Hospital
Investigators
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Principal Investigator: Zhenzhen Liu Study Principal Investigator Henan Cancer Hospital
More Information
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Responsible Party: Liuzhenzhen, Director, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT04547907    
Other Study ID Numbers: HNCH-BC006
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Carboplatin
 Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological