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Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer (NeoPATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03907800
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Li Zhu, Ruijin Hospital

Study Description
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Brief Summary:
To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.

Condition or disease Intervention/treatment Phase
Breast Cancer Triple Negative Breast Cancer HER2-positive Breast Cancer Drug: Nab-paclitaxel Drug: Carboplatin Drug: Herceptin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nab-paclitaxel + Carboplatin ± Herceptin Drug: Nab-paclitaxel
125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.

Drug: Carboplatin
AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles

Drug: Herceptin
In case of HER2-positive, patients receive Herceptin weekly during all cycles.


Outcome Measures
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Primary Outcome Measures :
  1. Pathological complete response (ypT0/is ypN0) rate [ Time Frame: 16 weeks (at the time of definitive surgery) ]
    Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.


Secondary Outcome Measures :
  1. Invasive disease-free survival (IDFS) [ Time Frame: 5 years ]
    IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer)

  2. Distant disease-free survival (DDFS) [ Time Frame: 5 years ]
    DDFS is defined as the time period between registration and first event (distant recurrence, death attributable to any cause, second primary nonbreast invasive cancer)

  3. Objective response rate (ORR) [ Time Frame: 16 weeks (at the time of definitive surgery) ]
    ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1

  4. Breast conservation rate [ Time Frame: 16 weeks (at the time of definitive surgery) ]
    To determine the breast conservation rate after neoadjuvant treatment.

  5. Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped [ Time Frame: during treatment (16 weeks) ]
    Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.


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

Inclusion Criteria:

  1. Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
  2. Age at diagnosis ≥ 18 years, female.
  3. Histologically confirmed diagnosis of HER2-opsitive or triple-negative breast cancer. ER/PR-negativity is defined as ≤1% stained cells； HER2-positivity is defined as IHC 3+ or in-situ hybridisation (ISH) ratio >2.0.
  4. cT2-4NanyM0 or cTanyN1-3M0
  5. ECOG ≤ 1, LVEF ≥ 55%.
  6. Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥ 1.5 × 109 / L and platelets ≥ 100 × 109 / L and hemoglobin ≥ 90 g/L; for hepatic function, total bilirubin ≤ 1.5 × UNL, AST and ALT ≤ 2.5 × UNL; for renal function, SCr ≤ 1.5 × UNL
  7. Patients must be available and compliant for treatment and follow-up.

Exclusion Criteria:

  1. Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy.
  2. Known or suspected congestive heart failure (> NYHA I)
  3. Currently active infection or severe symptomatic visceral disease.
  4. Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol
  5. rior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
  6. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
  7. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
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): NCT03907800


Contacts
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Contact: Jiayi Wu, Dr. 0086-21-64370045 ext 602268 pinkscorpio@163.com

Locations
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China
Ruijin Hospital Recruiting
Shanghai, China, 200025
Contact: Li Zhu, Prof.    0086-21-64370045 ext 602178    pinkscorpio@163.com   
Contact: Jiayi Wu, Dr.    0086-21-64370045 ext 602268    zhuli8@yeah.net   
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Li Zhu, Prof. Ruijin Hospital
More Information
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Responsible Party: Li Zhu, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03907800    
Other Study ID Numbers: RJBC1801
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

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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
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Carboplatin
 Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological