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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026499
Enrollment
Unknown
Registered
2019-10-12
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

control group:epirubicin combined with docetaxel

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
17 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. developing breast cancer as confirmed by X-ray examination, and cancer tissue is negative for estrogen receptor, progesterone receptor and HER2, and tumor stage II-III; 2. estimated survival > 3 months; 3. presence of clinically measurable lesions; 4. Karnofsky functional status score >=70; 5. normal blood routine and liver and kidney function, and generally normal electrocardiogram; 6. aged 18-70 years.

Exclusion criteria

Exclusion criteria: 1. stage IV breast cancer patients with bone metastasis or other distant metastasis; 2. severe renal insufficiency; 3. older adult patients with severe organic diseases such as heart and lung diseases, who are not estimated to be able to tolerate chemotherapy; 4. those who have received antineoplastic therapy (chemotherapy, radiotherapy, endocrine therapy, etc.); 5. those who received neoadjuvant chemotherapy but failed in 2 cycles of neoadjuvant chemotherapy and switched to other regimens or terminated chemotherapy; 6. those with history of other malignant tumors; 7. those with severe heart, liver, and kidney organ dysfunction or poor health who cannot tolerate chemotherapy, or those who cannot tolerate chemotherapy and switched to other therapeutic regimens; 8. those with mental and nervous system diseases who cannot comply with treatment; 9. those with dexamethasone intolerance or those who are highly allergic to any drug in neoadjuvant chemotherapy; 10. pregnant or lactating women; 11. those who are participating in other trials.

Design outcomes

Primary

MeasureTime frame
Pathologic complete remission rate;

Secondary

MeasureTime frame
Breast-conserving rate;Incidence of osteoporosis;Incidence of bone-related events;Incidence of other distant organ metastasis related events;Disease-free survival;Overall survival;Adverse events;

Countries

China

Contacts

Public ContactCaigang Liu

Shengjing Hospital of China Medical University

liucg@sj-hospital.org+86 18940254967

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026