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TC (Docetaxel/Carboplatin) Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxe) as Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT03154749
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
Shantou Central Hospital
Henan Provincial Hospital
Dongguan People's Hospital
Baotou Cancer Hospital
Yuebei People's Hospital
Information provided by (Responsible Party):
KunWang, Guangdong Provincial People's Hospital

Brief Summary:
Both TC (docetaxel/carboplatin) and EC followed by T (epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety of TC (docetaxel/carboplatin) and EC followed by T(epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment in Triple-Negative breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.

Condition or disease Intervention/treatment Phase
Triple-Negative Breast Cancer Drug: TC (docetaxel/carboplatin) versus EC followed by T (epirubicin/cyclophosphamide followed by docetaxe) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Prospective Randomized Trial of Docetaxel in Combination With Carboplatin(TC) Versus EC Followed by Docetaxel as Neoadjuvant Chemotherapy for Triple-Negative, Early-Stage Breast Cancer
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: TC
docetaxel/carboplatin as Neoadjuvant Treatment for Triple-Negative Breast Cancer
Drug: TC (docetaxel/carboplatin) versus EC followed by T (epirubicin/cyclophosphamide followed by docetaxe)
TC (docetaxel/carboplatin) versus EC followed by T (epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer

Active Comparator: EC-T
epirubicin/cyclophosphamide followed by docetaxe as Neoadjuvant Treatment for Triple-Negative Breast Cancer
Drug: TC (docetaxel/carboplatin) versus EC followed by T (epirubicin/cyclophosphamide followed by docetaxe)
TC (docetaxel/carboplatin) versus EC followed by T (epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer




Primary Outcome Measures :
  1. PCR [ Time Frame: one year ]
    pathologic complete response



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed Triple-Negative invasive breast carcinoma
  • Clinical stageⅠ-ⅢB
  • Patients must have measurable disease as defined by palpable lesion with caliper and/or a positive mammogram or ultrasound. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, x-rays and scans must be done within 28 days of study entry.
  • Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
  • Signed informed consent
  • Adequate organ function within 2 weeks of study entry: Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3 Total bilirubin < upper limit of normal Creatinine < 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) >50mL/min using the Cockcroft Gault equation serum glutamate oxaloacetate transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline Phosphatase must be within the range allowing for eligibility
  • Patients must be over 18 years old.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.

Exclusion Criteria:

  • Metastatic disease
  • Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone.
  • History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154749


Contacts
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Contact: Wang Kun, MD 00862083827812 ext 50910 gzwangkun@126.com
Contact: Zhang Liulu, MD

Locations
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China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Liming Yao    00862083827812 ext 20984    13149395530@163.com   
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Shantou Central Hospital
Henan Provincial Hospital
Dongguan People's Hospital
Baotou Cancer Hospital
Yuebei People's Hospital

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Responsible Party: KunWang, Professor, Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT03154749     History of Changes
Other Study ID Numbers: 20170512
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by KunWang, Guangdong Provincial People's Hospital:
Neoadjuvant chemotherapy
Triple-Negative Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Carboplatin
Docetaxel
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors