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

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ClinicalTrials.gov Identifier: NCT02879513
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Jinsong Lu, RenJi Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Invasive Ductal Breast Cancer Tubular Breast Cancer Mucinous Breast Cancer Inflammatory Breast Cancer Drug: Paclitaxel Drug: Cisplatin Drug: Epirubicin Drug: Cyclophosphamide Drug: 5-fluoruracil Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Comparing Combination Administration of Paclitaxel and Cisplatin Versus CEF as Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: Switch to CEF
Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks.
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: 5-fluoruracil
Other Name: 5-FU

Experimental: Continue the neoadjuvant regimen
Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.
Drug: Paclitaxel
Other Name: Taxol

Drug: Cisplatin
Experimental: Pathological complete response group with chemotherapy
Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.
Drug: Paclitaxel
Other Name: Taxol

Drug: Cisplatin
No Intervention: Pathological complete response group with no chemotherapy



Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: Up to 5 years ]
  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 4 months during adjuvant therapy ]
  3. regional recurrence free survival (RRFS) [ Time Frame: 5 years ]
  4. local recurrence free survival (LRFS) [ Time Frame: 5 years ]
  5. distant-disease- free survival (DDFS) [ Time Frame: 5 years ]


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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:

  1. Women aged ≥18years and ≤70 years;
  2. Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy.
  3. Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST).
  4. Endocrine therapy and trastuzumab were allowed to use.
  5. ECOG 0-2;
  6. 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;
  7. No obvious main organs dysfunction.

Exclusion Criteria:

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

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): NCT02879513


Contacts
Contact: Jinsong Lu, MD lujjss@163.com

Locations
China, Shanghai
Shanghai Jiaotong University School of Medicine, Renji Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: Jinsong Lu, MD       lujjss@163.com   
Sponsors and Collaborators
RenJi Hospital

Responsible Party: Jinsong Lu, Director of Department of Breast Surgery, RenJi Hospital
ClinicalTrials.gov Identifier: NCT02879513     History of Changes
Other Study ID Numbers: RenJiH-BC-003
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Skin Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Cyclophosphamide
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents