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CompletedNCT02199418SHPD001Updated Jan 25, 2017

Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer

A Phase 2 interventional study of Paclitaxel and Cisplatin in Tubular Breast Cancer, Mucinous Breast Cancer and Invasive Ductal Breast Cancer, sponsored by RenJi Hospital. Completed at 2 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by RenJi Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
132
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.

Read the detailed description

In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the trastuzumab.

02

Conditions studied

  • Tubular Breast Cancer
  • Mucinous Breast Cancer
  • Invasive Ductal Breast Cancer
  • Inflammatory Breast Cancer
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 132 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Women aged ≥18years and ≤70 years
  2. 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 N0-2M0
  3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PR positive is defined as >1% stained cells and HER2-positive is defined as immuno-histochemistry (IHC) 3+ or FISH ratio ≥ 2.0
  4. No prior systemic or loco-regional treatment of breast cancer
  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

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. Inflammatory breast cancer and 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
132 participants (actual)

Study arms

  • Experimental
    Paclitaxel and Cisplatin

    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. Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year

    Drug: Paclitaxel · Drug: Cisplatin

Interventions

  • DrugPaclitaxel

    Also known as: Taxol

  • DrugCisplatin
06

What researchers measure

Primary outcomes

  1. Pathological complete response of breast and lymph nodes

    Time frame: after 4 months preoperative treatment

Secondary outcomes

  1. Tolerability and Safety

    Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped

    Time frame: 4 months during neoadjuvant therapy

  2. Clinical and imaging response

    To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment

    Time frame: 4 months during treatment

  3. regional recurrence free survival (RRFS)

    RRFS is defined as the time period between registration and first event

    Time frame: 5 years

  4. local recurrence free survival (LRFS)

    LRFS is defined as the time period between registration and first event

    Time frame: 5 years

  5. distant-disease- free survival (DDFS)

    DFS is defined as the time period between registration and first event

    Time frame: 5 years

  6. overall survival (OS)

    OS is defined as the time period between registration and first event

    Time frame: 5 years

07

Study locations

2 sites
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
  • Shanghai Jiaotong University School of Medicine, Renji Hospital
    Shanghai, Shanghai 200127, China
08

References and documents

Publications

  • Sun L, Yin W, Wu Z, Wang Y, Lu J. The Predictive Value of Pre-therapeutic Serum Gamma-glutamyl transferase in Efficacy and Adverse Reactions to Neoadjuvant Chemotherapy among Breast Cancer Patients. J Breast Cancer. 2020 Oct;23(5):509-520. doi: 10.4048/jbc.2020.23.e59. PubMed 33154826 ↗
  • Wu Z, Zhang L, Xu S, Lin Y, Yin W, Lu J, Sha R, Sheng X, Zhou L, Lu J. Predictive and prognostic value of ZEB1 protein expression in breast cancer patients with neoadjuvant chemotherapy. Cancer Cell Int. 2019 Mar 29;19:78. doi: 10.1186/s12935-019-0793-2. eCollection 2019. PubMed 30976202 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02199418
Lead sponsor
RenJi Hospital
Responsible party
Jinsong Lu (Director of Breast Surgery, RenJi Hospital) — Principal investigator
First posted
Jul 24, 2014
Start date
Jan 2013
Primary completion
Nov 2015
Completion
Oct 2016
Last update
Jan 25, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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