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NCT04136782RecruitingPhase 4

Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer

Albumin-bound Paclitaxel Combined With Carboplatin Versus Epirubicin Combined With Docetaxel as Neoadjuvant Therapy for Triple-negative Breast Cancer: a Multicenter Randomized Controlled Phase IV Clinical Trial

Source: ClinicalTrials.gov · Last updated 20 Jul 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

To investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
110 (estimated)
First submitted
22 Oct 2019
Start date
19 Jul 2021
Primary completion date
30 Nov 2025
Lead sponsor
Shengjing Hospital
NCT number
NCT04136782

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 110
  • From 19 Jul 2021 to the primary completion date, 30 Nov 2025
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • those who have received antineoplastic therapy;
  • those who have received neoadjuvant chemotherapy but fail in 2 cycles of neoadjuvant chemotherapy and switch to other regimens or terminate chemotherapy;

Other illness

  • stage IV breast cancer patients with bone metastasis or other distant metastasis;
  • severe renal insufficiency;
  • older adult patients with severe organic diseases such as heart and lung diseases, who are not estimated to be able to tolerate chemotherapy;
  • those with history of other malignant tumors;
  • those with severe heart, liver, and kidney organ dysfunction or poor health who cannot tolerate chemotherapy, or those who cannot tolerate chemotherapy and switch to other therapeutic regimens;
  • those with mental and nervous system diseases who cannot comply with treatment;
  • those with dexamethasone intolerance or those who are highly allergic to any drug in neoadjuvant chemotherapy;

Other

  • pregnant or lactating women;
  • those who are participating in other trials.

Who the study is looking for

  • patients developing breast cancer as confirmed by X-ray examination, cancer tissue negative for estrogen receptor, progesterone receptor and HER2, and tumor stage II-III;
  • estimated survival \> 3 months;
  • presence of clinically measurable lesions;
  • Karnofsky functional status score ≥ 70;
  • normal routine blood test results, normal liver and kidney function, and near normal electrocardiographic manifestations;
  • age at 18-70 years.

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Hospital of Jilin University
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ChangchunChinaRecruiting
Dalian Municipal Central Hospital
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DalianChinaRecruiting
Cancer Hospital Affiliated to Harbin Medical University
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HarbinChinaRecruiting
Panjin Liaohe Oilfield Gem Flower Hospital
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PanjinChinaRecruiting
Liaoning Cancer Hospital & Institute
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ShenyangChinaRecruiting
The Fourth Affiliated Hospital of China Medical University
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ShenyangChinaRecruiting
Shengjing Hospital Of China Medical University
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.