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

Study acronym: SHPD002
StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Study sites: 8 to 12v9 Show 4 more changesShow less
    • Primary completion date: Dec 2018 to Jan 2019
    • Study completion date: Oct 2022 to Jan 2029
    • Start date: Jan 2014 to Sep 2013
    • Secondary endpoints: 9 to 10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Oct 2018 to Dec 2018
    • Site details revised at 8 of 8 sites
    v8
  3. Primary completion date: Jul 2018 to Oct 2018
    • Eligibility criteria revised
    v7
  4. Primary completion date: Jul 2017 to Jul 2018v6
  5. Secondary endpoints: 7 to 9v5
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  1. Enrollment target: 160 to 250v4 Show 7 more changesShow less
    • Primary completion date: Dec 2016 to Jul 2017
    • Study completion date: Oct 2017 to Oct 2022
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 61 words
    • Site contacts updated at 1 of 8 sites
    • Study title expanded, about 3 words
  2. Study sites: 1 to 8
    • Eligibility criteria revised
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RenJi Hospital
190 trials monitored
See 2 trials at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
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.
Trial Details
NCT Number NCT02221999
Lead Sponsor RenJi Hospital
Conditions
(from sponsor)		 Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Ductal Breast Cancer, Inflammatory Breast Cancer
Related terms Carcinoma, Ductal, Breast, Inflammatory Breast Neoplasms
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov