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NCT02221999Active, not recruitingPhase 2/3

Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients

A Prospective, Randomized, Open-label Comparison of Preoperative Weekly Paclitaxel and Cisplatin With or Without Endocrine Therapy in Patients With Operable Hormone Receptor Positive and Triple Negative Locally Advanced Breast Cancer

Source: ClinicalTrials.gov · Last updated 29 Aug 2023

Brief summary (registry, in English)

The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer. In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate. Premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
250 (estimated)
First submitted
14 Jul 2014
Start date
Sept 2013
Primary completion date
Jan 2019
Lead sponsor
RenJi Hospital
NCT number
NCT02221999

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 250
  • From Sept 2013 to the primary completion date, Jan 2019
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
  • Any concurrent malignancy other than breast cancer;

Other illness

  • Inflammatory breast cancer and 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;
  • Know severe hypersensitivity to any drugs in this study.

Other

  • Patient is pregnant or breast feeding;

Who the study is looking for

  • Women aged ≥18years and ≤70 years;
  • At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-3M0;
  • ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as \>1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals \>2.0 or HER2 gene copy \>6.0.
  • No prior systemic or loco-regional treatment of breast cancer;
  • Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count(ANC)≥1.5×109/L, Platelets(PLT)≥100×109/L, Hemoglobin(Hb)≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
  • No obvious main organs dysfunction.

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Handan Central Hospital
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HandanChinaUnknown status
The First Affiliated Hospital of University of South China
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HengyangChinaUnknown status
Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage
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HohhotChinaUnknown status
The second people's hospital of Kunshan city
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KunshanChinaUnknown status
Zhongshan Hospital
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ShanghaiChinaUnknown status
Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University
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ShanghaiChinaUnknown status
Shanghai Jiaotong University School of Medicine, Renji Hospital
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ShanghaiChinaUnknown status
Armed Police Corps Hospital of Shanghai
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ShanghaiChinaUnknown status
Yueyang hospital of integrated traditional Chinese and Western medine
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ShanghaiChinaUnknown status
Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital
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ShenzhenChinaUnknown status
Department of Medical Oncology, General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
Zhoushan hospital
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ZhoushanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.