NCT04664972

Brief Summary

Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for TNBC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 23, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2022

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

4 years

First QC Date

November 9, 2020

Last Update Submit

September 18, 2024

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • The pathological complete remission rate (pCR rate)

    Pathological complete response rate (PCR rate), which means there is no invasive cancer (i.e. ypT0/is, ypN0) in the excised specimen (breast+lymphnode) following neoadjuvant chemotherapy and surgery.

    Immediately after surgery

Secondary Outcomes (4)

  • Event free survival rate (EFS)

    5 years after surgery

  • Clinical response rate (CRR)

    before breast cancer surgery

  • Breast -conserving rate

    up to 24 weeks

  • Number of adverse events and serious adverse events

    After each cycle of chemotherapy (21 days as 1 cycle)

Study Arms (2)

TAC regimen group

PLACEBO COMPARATOR

The control group was treated with TAC (docetaxel 75mg/m2 + adriamycin 50mg /m2 + cyclophosphamide 500mg/m2) for 6 cycles, 21 days as a cycle.

Drug: Docetaxel +doxorubicin+ cyclophosphamide

TP regimen group

EXPERIMENTAL

The experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle.

Drug: Docetaxel +Cisplatin

Interventions

Docetaxel +doxorubicin+ cyclophosphamideDRUG

The control group was treated with TAC (docetaxel 75 mg / m2 + adriamycin 50 mg / m2 + cyclophosphamide 500 mg / m2) for 6 cycles, 21 days was a cycle.

Also known as: TAC regimen group
TAC regimen group
Docetaxel +CisplatinDRUG

The experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle.

Also known as: TP regimen group
TP regimen group

Eligibility Criteria

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

You may qualify if:

  • Age: 18-70.
  • Clinical stage Ⅱ-Ⅲ.
  • triple negative and invasive breast cancer confirmed by histopathology:
  • Triple negative breast cancer is defined as:
  • negative for ER and PR (IHC nuclear staining \< 10%).
  • Her-2 negative (IHC 0,1 + without FISH, or IHC 2 + and without FISH amplification).
  • With clinically measurable focus: Measurable lesions observed on ultrasound, mammography, or magnetic resonance imaging (optional) within the month prior to randomization.
  • Organ and bone marrow function tests within 1 month before chemotherapy indicate no contraindications to chemotherapy:
  • neutrophils count absolute value ≥ 2.0×109/L
  • hemoglobin ≥ 100g/L
  • blood platelet ≥ 100×109/L
  • total bilirubin \< 1.5 ULN (upline of normal value)
  • creatinine \< 1.5×ULN
  • AST/ALT \< 1.5×ULN;
  • Cardiac ultrasound EF value ≥ 55%.
  • +3 more criteria

You may not qualify if:

  • Evidence of metastatic breast cancer (excluding metastatic breast cancer, a chest CT, abdominal ultrasound, or CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging examination mean) .
  • The patients have received chemotherapy, endocrine therapy, targeted therapy, and radiation therapy for this disease.
  • The patient has a second primary malignant tumor, except for:
  • \- Thoroughly treated skin cancer
  • Due to severe and uncontrollable other medical diseases, researchers believe the existence of chemotherapy contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Zhenzhen Liu

    Henan Cancer Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 9, 2020

First Posted

December 11, 2020

Study Start

November 23, 2018

Primary Completion

November 26, 2022

Study Completion

November 26, 2022

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations

CN(1)