Back to results

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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Pegylated Liposomal Doxorubicin

Albumin-bound paclitaxel

Trastuzumab

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

New York Heart Association (NYHA) class ≥Ⅱ heart failure.
Known or suspected hypersusceptibility to any agents used in the treatment protocol.
Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator.
participating in other clinical trials within 4 weeks before this study.
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.

Sites / Locations

Fei MaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PLD/albumin-bound paclitaxel/Trastuzumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Pathological complete response(pCR) rate

Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery

Secondary Outcome Measures

Rate of Breast conserving surgery

Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy

Rate of surgery

Percentage of patients undergoing mastectomy and breast-conserving surgery after neoadjuvant therapy

adverse events

Incidence and Severity of adverse events ,according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0

Full Information

NCT ID

NCT03994107

First Posted

June 19, 2019

Last Updated

January 20, 2020

Sponsor

Peking Union Medical College

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03994107

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

January 1, 2021 (Anticipated)

Study Completion Date

January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PLD/albumin-bound paclitaxel/Trastuzumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pegylated Liposomal Doxorubicin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Albumin-bound paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Pathological complete response(pCR) rate

Description

Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery

Time Frame

5 months

Secondary Outcome Measure Information:

Title

Rate of Breast conserving surgery

Description

Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy

Time Frame

5 months

Title

Rate of surgery

Description

Percentage of patients undergoing mastectomy and breast-conserving surgery after neoadjuvant therapy

Time Frame

5 months

Title

adverse events

Description

Incidence and Severity of adverse events ,according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0

Time Frame

5 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document; Female patients aged from 18 to 70 years old; Histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible; Clinical stageⅡ-Ⅲ; HER-2 Positive（defined by: IHC 3+ or ISH positive）; Without previous treatment for this breast cancer; Patients must have at least one measurable disease according to RECIST 1.1; ECOG (Eastern Cooperative Oncology Group) performance score of 0-1 points; LVEF≥55%; Normal ECG; Bone marrow function:absolute neutrophil count (ANC)≥2.0×109/L，platelets≥100×109/L，hemoglobin ≥90g/L。 Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤1.5×ULN，serum total bilirubin≤ ULN; 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: New York Heart Association (NYHA) class ≥Ⅱ heart failure. Known or suspected hypersusceptibility to any agents used in the treatment protocol. Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator. participating in other clinical trials within 4 weeks before this study. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fei Ma, MD

Phone

+8613910217780

13910217780@139.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fei Ma, MD

Organizational Affiliation

Cancer Hospital Chinese Academy of Medical Science

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fei Ma

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fei Ma, MD

Phone

+86-10-87787652

mafei@126.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs