Skip to main content
OpenTrials
Completed

NCT Number: NCT02199418

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 N0-2M0
  • 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
  • No prior systemic or loco-regional treatment of breast cancer
  • ECOG 0-2
  • 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

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
  • 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
  • Any concurrent malignancy other than breast cancer
  • Know severe hypersensitivity to any drugs in this study

Treatment and study plan

paclitaxel

Drug

Other names: Taxol

Cisplatin

Drug

Primary outcomes

  1. Pathological complete response of breast and lymph nodes

    Time frame: after 4 months preoperative treatment

Secondary outcomes

  1. Tolerability and Safety

    Time frame: 4 months during neoadjuvant therapy

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

  2. Clinical and imaging response

    Time frame: 4 months during treatment

    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

  3. regional recurrence free survival (RRFS)

    Time frame: 5 years

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

  4. local recurrence free survival (LRFS)

    Time frame: 5 years

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

  5. distant-disease- free survival (DDFS)

    Time frame: 5 years

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

  6. overall survival (OS)

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients

Acronym: SHPD001

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 24, 2014
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.