Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    290
  • sponsor
    RenJi Hospital
Updated on 24 January 2021
paclitaxel
cancer
cyclophosphamide
absolute neutrophil count
breast cancer
endocrine therapy
neutrophil count
hormone therapy
advanced breast cancer
trastuzumab
locally advanced breast cancer
epirubicin
adjuvant chemotherapy

Summary

This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.

Description

All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.

Details
Condition Invasive Ductal Breast Carcinoma, Breast Cancer, Inflammatory Breast Cancer, Tubular Breast Cancer, Mucinous Breast Cancer, inflammatory breast cancers
Treatment cyclophosphamide, cisplatin, Epirubicin, Paclitaxel, 5-fluoruracil
Clinical Study IdentifierNCT02879513
SponsorRenJi Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Are you female?
Do you have any of these conditions: Tubular Breast Cancer or Inflammatory Breast Cancer or Breast Cancer or Invasive Ductal Breast Carcinoma or Mucinous Breast Cancer?
Do you have any of these conditions: Invasive Ductal Breast Carcinoma or Mucinous Breast Cancer or inflammatory breast cancers or Inflammatory Breast Cancer or Tubular Breast Cancer or Br...?
Women aged 18years and 70 years
Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy
Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Endocrine therapy and trastuzumab were allowed to use
ECOG 0-2
Adequate bone marrow function:WBC4.0109/L, Absolute neutrophil countANC1.5109/L, PlateletsPLT100109/L, HemoglobinHb90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)1.5 upper normal limit (UNL), creatinine1.5 UNL, bilirubin1.5UNL
No obvious main organs dysfunction

Exclusion Criteria

Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug
Patient is pregnant or breast feeding
Metastatic breast cancer
Any evidence of sense or motor nerve disorders
Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection
Any concurrent malignancy other than breast cancer
Know severe hypersensitivity to any drugs in this study
Clear my responses

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