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

NCT ID: NCT03994107

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-01-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pegylated Liposomal Doxorubicin

Intervention Type: DRUG

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

Second phase

PLD：MTD. IV, d1, q21d×6.

Albumin-bound paclitaxel

Intervention Type: DRUG

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

Trastuzumab

Intervention Type: DRUG

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

Interventions

Pegylated Liposomal Doxorubicin

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

Second phase

PLD：MTD. IV, d1, q21d×6.

Intervention Type: DRUG

Albumin-bound paclitaxel

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

Intervention Type: DRUG

Trastuzumab

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking Union Medical College

OTHER

Sponsor Role: lead

Responsible Party

Fei Ma

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fei Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Science

Locations

Fei Ma

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fei Ma, MD

Role: CONTACT

13910217780@139.com

+8613910217780

Facility Contacts

Fei Ma, MD

Role: primary

mafei@126.com

+86-10-87787652

Other Identifiers

CSPC-DMS-BC-17

Identifier Type: -

Identifier Source: org_study_id