NCT04136782

Brief Summary

To investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4 breast-cancer

Timeline
6mo left

Started Jul 2021

Longer than P75 for phase_4 breast-cancer

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2021Nov 2026

First Submitted

Initial submission to the registry

October 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 19, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

4.4 years

First QC Date

October 22, 2019

Last Update Submit

July 18, 2021

Conditions

Breast Cancer

Keywords

adjuvant chemotherapypaclitaxelalbumin-bound paclitaxelcarboplatindocetaxelepirubicin

Outcome Measures

Primary Outcomes (1)

  • Pathologic complete remission rate

    Pathologic complete remission will be evaluated 5 years after treatment according to the regression of tumors. Tumor regression will be assessed according to RECIST 1.1. Complete remission (CR)

    5 years after treatment

Secondary Outcomes (7)

  • Breast-conserving rate

    After 6 months of treatment

  • Incidence of osteoporosis

    Every 6 months for 5 successive years

  • Incidence of bone-related events

    Every 6 months for 5 successive years

  • Incidence of other distant organ metastasis related events

    Every 6 months for 5 successive years

  • Disease-free survival (DFS)

    Within 5 years after disease onset.

  • +2 more secondary outcomes

Study Arms (2)

Trial group

EXPERIMENTAL

55 cases of triple-negative breast cancer will be assigned into a trial group.

Drug: Albumin-bound paclitaxel combined with carboplatin

Control group

ACTIVE COMPARATOR

55 cases of triple-negative breast cancer will be assigned into a control group.

Drug: Epirubicin combined with docetaxel

Interventions

Albumin-bound paclitaxel combined with carboplatinDRUG

Albumin-bound paclitaxel combined with carboplatin: Albumin-bound paclitaxel (Abraxis BioScience, LLC., Mclrose Park, IL, USA; certificate number: H20091059) will be intravenously administered at 125 mg/m2 for 30 minutes on days 1 and 8 of each 21-day session of treatment. There will be six 21-day sessions of treatment. At the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; National Drug Approval Number: H20020181) will be intravenously administered at AUC = 2 mg•min/mL for 120 minutes on days 1 and 8 of each 21-day session of treatment. Carboplatin must be hydrated for 3 days before use to prevent nephrotoxicity.

Also known as: Albumin-bound paclitaxel+carboplatin group
Trial group
Epirubicin combined with docetaxelDRUG

Epirubicin (Pfizer Pharmaceutical (Wuxi) Co., Ltd., China; National Drug Approval Number: H20000496) will be intravenously administered at 90 mg/m2 for 120 minutes on day 1 of each 21-day session of treatment. At the same time, docetaxel (Sanofi-aventis Deutschland GmbH, Frankfurt am Main, Germany; National Drug Approval Number: J20150083) will be intravenously administered at 75 mg/m2 for 120 minutes. Drug administration will be performed once every other 3 weeks for four times.

Also known as: Epirubicin+docetaxel group
Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients developing breast cancer as confirmed by X-ray examination, cancer tissue negative for estrogen receptor, progesterone receptor and HER2, and tumor stage II-III;
  • estimated survival \> 3 months;
  • presence of clinically measurable lesions;
  • Karnofsky functional status score ≥ 70;
  • normal routine blood test results, normal liver and kidney function, and near normal electrocardiographic manifestations;
  • age at 18-70 years.

You may not qualify if:

  • stage IV breast cancer patients with bone metastasis or other distant metastasis;
  • severe renal insufficiency;
  • older adult patients with severe organic diseases such as heart and lung diseases, who are not estimated to be able to tolerate chemotherapy;
  • those who have received antineoplastic therapy;
  • those who have received neoadjuvant chemotherapy but fail in 2 cycles of neoadjuvant chemotherapy and switch to other regimens or terminate chemotherapy;
  • those with history of other malignant tumors;
  • those with severe heart, liver, and kidney organ dysfunction or poor health who cannot tolerate chemotherapy, or those who cannot tolerate chemotherapy and switch to other therapeutic regimens;
  • those with mental and nervous system diseases who cannot comply with treatment;
  • those with dexamethasone intolerance or those who are highly allergic to any drug in neoadjuvant chemotherapy;
  • pregnant or lactating women;
  • those who are participating in other trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, 150081, China

RECRUITING

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

RECRUITING

Dalian Municipal Central Hospital

Dalian, Liaoning, 116033, China

RECRUITING

Panjin Liaohe Oilfield Gem Flower Hospital

Panjin, Liaoning, 124010, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110032, China

RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CarboplatinDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Caigang Liu, M.D., Ph.D.

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Gu, M.D.

CONTACT

+86 18940255116jadegx@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 23, 2019

Study Start

July 19, 2021

Primary Completion

November 30, 2025

Study Completion (Estimated)

November 30, 2026

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

CN(7)