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Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer

Primary Purpose

Breast Cancer Stage

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

nab-paclitaxel

About this trial

This is an interventional treatment trial for Breast Cancer Stage focused on measuring Breast cancer; neoadjuvant therapy; Nab-paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed content obtained prior to treatment. The patients were fully explained and understood the purpose, contents, predicted efficacy, pharmacological effects, and risks of this study.
target population 1)The histologic diagnosis of the primary invasive breast cancer and clinical stage I - III, first option Ⅳ period; 2) One of the following conditions:Large mass (>3cm);Axillary lymph node metastasis;her-2 positive; tri-negative; For those who are willing to preserve breast, but have difficulty in breast conserving due to the large proportion of tumor size and breast volume; 3) The clinician determined that the patient was suitable for the treatment with albumin-binding taxol regimen;4) The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study 5)No contraindications for nab-paclitaxel.
Age and reproductive status 1) Age ≥ 18 years 2) Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 24 hours before the start of chemotherapy; 3) Women must not lactate.

Exclusion Criteria:

Allergy to paclitaxel for injection (albumin binding) and/or its adjuvants has been demonstrated;
Pregnant or lactating women
Abnormal results of physical examination and laboratory examination 1) Absolute neutrophil count (ANC) 90g/L 1.5 × 109/L; Platelets (PLT) 90g/L 100 × 109/L; Hemoglobin (Hgb) < 90g/L 2) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) >2.5 × institutional upper limit of normal (ULN), >5 × institutional upper limit of normal (ULN) (hepatic metastases); Total bilirubin (TBIL)>1.5 × ULN; 3) Creatinine (CRE)> 1.5 × ULN 4) Prothrombin time (PT) and international normalized ratio (INR) > 1.5 × ULN. Unless the subject had received anticoagulant treatment
Paclitaxel for injection (albumin binding type) contraindications in patients
Participating in clinical trials of other taxoids
Patients with concomitant other tumors, other than cured carcinoma in situ of the cervix and non-melanoma skin cancer
Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
The researchers considered that there were other conditions that were not suitable for enrollment.

Sites / Locations

the first hospital of Jilin University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nab-paclitaxel

Arm Description

nab-paclitaxel monotherapy or combination therapeutic regimen

Outcomes

Primary Outcome Measures

the Pathological complete remission(pCR)

Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens.

Disease-free survival (DFS)

defined as the time from the beginning of randomization to recurrence or death due to disease progression

Secondary Outcome Measures

the overall survival (OS)

defined as the time between enrollment in the study (i.e., ICF) and death from any cause.Subjects who survived the last contact were deleted on the last contact date

Breast conserving rate

after neoadjuvant treatment, the percentage of patients undergoing breast conserving surgery in the total number of evaluable cases.

Full Information

NCT ID

NCT03959397

First Posted

May 16, 2019

Last Updated

May 21, 2019

Sponsor

Jilin University

1. Study Identification

Unique Protocol Identification Number

NCT03959397

Brief Title

Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer

Official Title

A Real-world Study of Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2019 (Anticipated)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Neoadjuvant chemotherapy is a systemic cytotoxic drug therapy for non-metastatic tumors before local therapy, Now it has become an important part of standard treatment for a stage II, III, and the first clinical Ⅳ breast cancer .Both domestic and foreign authoritative guidelines recommend the use of albumin-binding paclitaxel in the neoadjuvant treatment of breast cancer .In addition, clinical studies at home and abroad have preliminarily confirmed the application value and therapeutic benefit of albumin-binding paclitaxel in breast cancer neoadjuvant therapy, and the toxic and side effects can be tolerated.

Detailed Description

Data were collected on the efficacy and safety of neoadjuvant therapy in patients receiving albumin-binding taxol regimens,Subgroup analysis was performed for different treatment regimens, dosages, molecular subtypes and tumor stages,To further screen the dominant population and the chemotherapy regimen with clinical benefit of albumin paclitaxel, so as to provide evidence-based medical evidence for breast cancer neoadjuvant clinical diagnosis and treatment.

6. Conditions and Keywords

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

Breast Cancer Stage

Keywords

Breast cancer; neoadjuvant therapy; Nab-paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nab-paclitaxel

Arm Type

Experimental

Arm Description

nab-paclitaxel monotherapy or combination therapeutic regimen

Intervention Type

Drug

Intervention Name(s)

nab-paclitaxel

Other Intervention Name(s)

ABRAXANE ，Albumin-binding paclitaxel

Intervention Description

nab-paclitaxel monotherapy or combination therapeutic regimen

Primary Outcome Measure Information:

Title

the Pathological complete remission(pCR)

Description

Time Frame

2 weeks

Title

Disease-free survival (DFS)

Description

defined as the time from the beginning of randomization to recurrence or death due to disease progression

Time Frame

6 months

Secondary Outcome Measure Information:

Title

the overall survival (OS)

Description

defined as the time between enrollment in the study (i.e., ICF) and death from any cause.Subjects who survived the last contact were deleted on the last contact date

Time Frame

6 months

Title

Breast conserving rate

Description

after neoadjuvant treatment, the percentage of patients undergoing breast conserving surgery in the total number of evaluable cases.

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Adverse events (AE)

Description

Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed content obtained prior to treatment. The patients were fully explained and understood the purpose, contents, predicted efficacy, pharmacological effects, and risks of this study. target population 1)The histologic diagnosis of the primary invasive breast cancer and clinical stage I - III, first option Ⅳ period; 2) One of the following conditions:Large mass (>3cm);Axillary lymph node metastasis;her-2 positive; tri-negative; For those who are willing to preserve breast, but have difficulty in breast conserving due to the large proportion of tumor size and breast volume; 3) The clinician determined that the patient was suitable for the treatment with albumin-binding taxol regimen;4) The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study 5)No contraindications for nab-paclitaxel. Age and reproductive status 1) Age ≥ 18 years 2) Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 24 hours before the start of chemotherapy; 3) Women must not lactate. Exclusion Criteria: Allergy to paclitaxel for injection (albumin binding) and/or its adjuvants has been demonstrated; Pregnant or lactating women Abnormal results of physical examination and laboratory examination 1) Absolute neutrophil count (ANC) 90g/L 1.5 × 109/L; Platelets (PLT) 90g/L 100 × 109/L; Hemoglobin (Hgb) < 90g/L 2) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) >2.5 × institutional upper limit of normal (ULN), >5 × institutional upper limit of normal (ULN) (hepatic metastases); Total bilirubin (TBIL)>1.5 × ULN; 3) Creatinine (CRE)> 1.5 × ULN 4) Prothrombin time (PT) and international normalized ratio (INR) > 1.5 × ULN. Unless the subject had received anticoagulant treatment Paclitaxel for injection (albumin binding type) contraindications in patients Participating in clinical trials of other taxoids Patients with concomitant other tumors, other than cured carcinoma in situ of the cervix and non-melanoma skin cancer Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period. The researchers considered that there were other conditions that were not suitable for enrollment.

Central Contact Person:

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

Fan zhimin, Doctor

Phone

13904321567

13364308696@163.com

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

Shi aiping

Phone

15804301451

13364308696@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fan zhimin, Doctor

Organizational Affiliation

First Affiliated Hospital of Jilin University

Official's Role

Study Director

Facility Information:

Facility Name

the first hospital of Jilin University

City

Jilin

State/Province

Changchun

ZIP/Postal Code

130021

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26869049

Citation

Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kummel S, Hilfrich J, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Darb-Esfahani S, Schmitt WD, Dan Costa S, Gerber B, Engels K, Nekljudova V, Loibl S, von Minckwitz G; German Breast Group (GBG); Arbeitsgemeinschaft Gynakologische Onkologie-Breast (AGO-B) Investigators. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8. Erratum In: Lancet Oncol. 2016 Jul;17 (7):e270.

Results Reference

background

PubMed Identifier

29228315

Citation

Gluz O, Nitz U, Liedtke C, Christgen M, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Bangemann N, Lindner C, Kuemmel S, Clemens M, Potenberg J, Staib P, Kohls A, von Schumann R, Kates R, Kates R, Schumacher J, Wuerstlein R, Kreipe HH, Harbeck N. Comparison of Neoadjuvant Nab-Paclitaxel+Carboplatin vs Nab-Paclitaxel+Gemcitabine in Triple-Negative Breast Cancer: Randomized WSG-ADAPT-TN Trial Results. J Natl Cancer Inst. 2018 Jun 1;110(6):628-637. doi: 10.1093/jnci/djx258.

Results Reference

background

PubMed Identifier

28061451

Citation

Zong Y, Wu J, Shen K. Nanoparticle albumin-bound paclitaxel as neoadjuvant chemotherapy of breast cancer: a systematic review and meta-analysis. Oncotarget. 2017 Mar 7;8(10):17360-17372. doi: 10.18632/oncotarget.14477.

Results Reference

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PubMed Identifier

27393622

Citation

Nahleh ZA, Barlow WE, Hayes DF, Schott AF, Gralow JR, Sikov WM, Perez EA, Chennuru S, Mirshahidi HR, Corso SW, Lew DL, Pusztai L, Livingston RB, Hortobagyi GN. SWOG S0800 (NCI CDR0000636131): addition of bevacizumab to neoadjuvant nab-paclitaxel with dose-dense doxorubicin and cyclophosphamide improves pathologic complete response (pCR) rates in inflammatory or locally advanced breast cancer. Breast Cancer Res Treat. 2016 Aug;158(3):485-95. doi: 10.1007/s10549-016-3889-6. Epub 2016 Jul 8.

Results Reference

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Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer

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