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
- Diseases
- Triple-negative breast cancer
- 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
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Dalian Municipal Central Hospital Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| Cancer Hospital Affiliated to Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| Panjin Liaohe Oilfield Gem Flower Hospital Coordinator of this site? Confirm its status | Panjin | China | Recruiting |
| Liaoning Cancer Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| The Fourth Affiliated Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.