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出境医 / 临床实验 / Pegylated Liposomal Doxorubicin Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer

Pegylated Liposomal Doxorubicin Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer

Study Description
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（PLD）plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Pegylated Liposomal Doxorubicin Drug: Albumin-bound paclitaxel Drug: Trastuzumab Phase 1 Phase 2

Detailed Description:

This is a single-center, prospective, single arm phase II study. Eligible patients will receive neoadjuvant therapy with pegylated liposome doxorubicin (PLD)/albumin-bound paclitaxel/trastuzumab regimentation.

This study consists of two phases, the first phase aims to determine the maximum tolerated dose (MTD) of PLD, and the second phase will explore the efficacy and safety of the regimen.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Prospective, Single Arm Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin（PLD）Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: PLD/albumin-bound paclitaxel/Trastuzumab

First phase

PLD: Level 1：30mg/m2； Level 2：35mg/m2； Level 3：40mg/m2； IV, d1, q21d×6.

albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.

Trastuzumab：8mg/kg IV for the first infusion , Subsequent infusions 6mg/kg. d1, q21d×6.

Second phase

PLD: maximum tolerated dose (MTD). IV, d1, q21d×6.

albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.

Trastuzumab：8mg/kg IV for the first infusion ,Subsequent infusions 6mg/kg. d1, q21d×6.

 Drug: Pegylated Liposomal Doxorubicin

First phase PLD: 30mg/m2；35mg/m2；40mg/m2；IV, d1, q21d×6.

Second phase

PLD：MTD. IV, d1, q21d×6.


Drug: Albumin-bound paclitaxel
220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.

Drug: Trastuzumab
8mg/kg IV for the first infusion. Subsequent infusions 6mg/kg. d1, q21d×6.
Outcome Measures
Primary Outcome Measures :
  1. Pathological complete response(pCR) rate [ Time Frame: 5 months ]
    Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery


Secondary Outcome Measures :
  1. Rate of Breast conserving surgery [ Time Frame: 5 months ]
    Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy

  2. Rate of surgery [ Time Frame: 5 months ]
    Percentage of patients undergoing mastectomy and breast-conserving surgery after neoadjuvant therapy

  3. adverse events [ Time Frame: 5 months ]
    Incidence and Severity of adverse events ,according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document;
  2. Female patients aged from 18 to 70 years old;
  3. Histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible;
  4. Clinical stageⅡ-Ⅲ;
  5. HER-2 Positive（defined by: IHC 3+ or ISH positive）;
  6. Without previous treatment for this breast cancer;
  7. Patients must have at least one measurable disease according to RECIST 1.1;
  8. ECOG (Eastern Cooperative Oncology Group) performance score of 0-1 points;
  9. LVEF≥55%;
  10. Normal ECG;
  11. Bone marrow function:absolute neutrophil count (ANC)≥2.0×109/L，platelets≥100×109/L，hemoglobin ≥90g/L。
  12. Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤1.5×ULN，serum total bilirubin≤ ULN;
  13. Renal function：serum creatinine≤1.5×ULN； Coagulation function：the international standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) or the activated partial thrombin time (APTT) ≤1.5×ULN.

Exclusion Criteria:

  1. New York Heart Association (NYHA) class ≥Ⅱ heart failure.
  2. Known or suspected hypersusceptibility to any agents used in the treatment protocol.
  3. Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator.
  4. participating in other clinical trials within 4 weeks before this study.
  5. Serious heart disease, including but not limited to:

1) Significant ventricular arrhythmia or high degree atrioventricular block (Mobitz II or third degree atrioventricular block); 2) unstable angina; 3) clinically significant heart valve disease; 4) Electrocardiogram shows transmural myocardial infarction; 5) Uncontrolled hypertension. 6. Uncontrolled diabetes. 7. Severe or uncontrolled infection. 8. Hepatitis b surface antigen positive, or hepatitis c virus antibody positive, or human immunodeficiency virus (HIV) antibody positive.

9. Active malignancy, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin，within the past 5 years.

9）Women who are pregnant , breastfeeding ,or refuse to use adequate contraception prior to study entry and for the duration of study participation.

10）Other conditions considered to be inappropriate to be enrolled by the investigator.

Contacts and Locations

Contacts
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Contact: Fei Ma, MD +8613910217780 13910217780@139.com

Locations
Layout table for location information
China, Beijing
Fei Ma Recruiting
Beijing, Beijing, China, 100021
Contact: Fei Ma, MD    +86-10-87787652    mafei@126.com   
Sponsors and Collaborators
Peking Union Medical College
CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Fei Ma, MD Cancer Hospital Chinese Academy of Medical Science
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		Pathological complete response(pCR) rate [ Time Frame: 5 months ]
Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Rate of Breast conserving surgery [ Time Frame: 5 months ]
    Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy
  • Rate of surgery [ Time Frame: 5 months ]
    Percentage of patients undergoing mastectomy and breast-conserving surgery after neoadjuvant therapy
  • adverse events [ Time Frame: 5 months ]
    Incidence and Severity of adverse events ,according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pegylated Liposomal Doxorubicin Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer
Official Title  ICMJE A Single-center, Prospective, Single Arm Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin（PLD）Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer
Brief Summary The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（PLD）plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.
Detailed Description

This is a single-center, prospective, single arm phase II study. Eligible patients will receive neoadjuvant therapy with pegylated liposome doxorubicin (PLD)/albumin-bound paclitaxel/trastuzumab regimentation.

This study consists of two phases, the first phase aims to determine the maximum tolerated dose (MTD) of PLD, and the second phase will explore the efficacy and safety of the regimen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Pegylated Liposomal Doxorubicin

    First phase PLD: 30mg/m2；35mg/m2；40mg/m2；IV, d1, q21d×6.

    Second phase

    PLD：MTD. IV, d1, q21d×6.

  • Drug: Albumin-bound paclitaxel
    220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
  • Drug: Trastuzumab
    8mg/kg IV for the first infusion. Subsequent infusions 6mg/kg. d1, q21d×6.
Study Arms  ICMJE Experimental: PLD/albumin-bound paclitaxel/Trastuzumab

First phase

PLD: Level 1：30mg/m2； Level 2：35mg/m2； Level 3：40mg/m2； IV, d1, q21d×6.

albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.

Trastuzumab：8mg/kg IV for the first infusion , Subsequent infusions 6mg/kg. d1, q21d×6.

Second phase

PLD: maximum tolerated dose (MTD). IV, d1, q21d×6.

albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.

Trastuzumab：8mg/kg IV for the first infusion ,Subsequent infusions 6mg/kg. d1, q21d×6.

Interventions:
  • Drug: Pegylated Liposomal Doxorubicin
  • Drug: Albumin-bound paclitaxel
  • Drug: Trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document;
  2. Female patients aged from 18 to 70 years old;
  3. Histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible;
  4. Clinical stageⅡ-Ⅲ;
  5. HER-2 Positive（defined by: IHC 3+ or ISH positive）;
  6. Without previous treatment for this breast cancer;
  7. Patients must have at least one measurable disease according to RECIST 1.1;
  8. ECOG (Eastern Cooperative Oncology Group) performance score of 0-1 points;
  9. LVEF≥55%;
  10. Normal ECG;
  11. Bone marrow function:absolute neutrophil count (ANC)≥2.0×109/L，platelets≥100×109/L，hemoglobin ≥90g/L。
  12. Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤1.5×ULN，serum total bilirubin≤ ULN;
  13. Renal function：serum creatinine≤1.5×ULN； Coagulation function：the international standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) or the activated partial thrombin time (APTT) ≤1.5×ULN.

Exclusion Criteria:

  1. New York Heart Association (NYHA) class ≥Ⅱ heart failure.
  2. Known or suspected hypersusceptibility to any agents used in the treatment protocol.
  3. Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator.
  4. participating in other clinical trials within 4 weeks before this study.
  5. Serious heart disease, including but not limited to:

1) Significant ventricular arrhythmia or high degree atrioventricular block (Mobitz II or third degree atrioventricular block); 2) unstable angina; 3) clinically significant heart valve disease; 4) Electrocardiogram shows transmural myocardial infarction; 5) Uncontrolled hypertension. 6. Uncontrolled diabetes. 7. Severe or uncontrolled infection. 8. Hepatitis b surface antigen positive, or hepatitis c virus antibody positive, or human immunodeficiency virus (HIV) antibody positive.

9. Active malignancy, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin，within the past 5 years.

9）Women who are pregnant , breastfeeding ,or refuse to use adequate contraception prior to study entry and for the duration of study participation.

10）Other conditions considered to be inappropriate to be enrolled by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fei Ma, MD +8613910217780 13910217780@139.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994107
Other Study ID Numbers  ICMJE CSPC-DMS-BC-17
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fei Ma, Peking Union Medical College
Study Sponsor  ICMJE Peking Union Medical College
Collaborators  ICMJE CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators  ICMJE
Principal Investigator: Fei Ma, MD Cancer Hospital Chinese Academy of Medical Science
PRS Account Peking Union Medical College
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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