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A prospective, open-label, multicenter clinical study for the efficacy and safety of paclitaxel (albumin-binding) combined with AC chemotherapy in the treatment of postoperative breast cancer

A prospective, open-label, multicenter clinical study for the efficacy and safety of paclitaxel (albumin-binding) combined with AC chemotherapy in the treatment of postoperative breast cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022560
Enrollment
Unknown
Registered
2019-04-16
Start date
2019-05-02
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

Breast cancer

Interventions

Case series:Paclitaxel (albumin-bound) + anthracycline + cyclophosphamide

Sponsors

Chongqing Three Gorges Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. A breast cancer patient diagnosed by histopathology or cytology; 2. Female aged 18 to 70 years old; 3. The primary lesion can be operated without distal metastases, undergoing breast cancer resection and total internal thoracic lymph node dissection; surgical resection is R0 resection; 4. The time to start adjuvant therapy is 7-14 days is appropriate; 5. If the platinum or taxane regimen is effective (CR PR), the time of injection of paclitaxel (albumin-binding) is =3 months from the last use of platinum or taxane; 6. The expected life expectancy is greater than 3 months; 7. ECOG PS 0-3 points; 8. The patient's bone marrow reserve is good (peripheral white blood cell count > 4 ×10^9/L, platelet count > 100 × 10^9/L and liver and kidney function is basically normal; 9. Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to apply appropriate during the trial and 8 weeks after the last administration of the test drug. Method of contraception; 10. Do not synchronize with tamoxifen or postoperative radiation therapy during adjuvant chemotherapy; 11. Subjects volunteered to participate in the study, with good adherence and follow-up.

Exclusion criteria

Exclusion criteria: 1. Those who have been severely allergic to paclitaxel have been confirmed; 2. Patients with severe heart, kidney and liver dysfunction; 3. Cognitive dysfunction cannot be communicated normally; 4. Those who have hypertension and cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 5. Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval = 470 ms); according to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac ultrasound Check for a left ventricular ejection fraction (LVEF) Level 2); 17. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; 18. The investigator judges other conditions that may affect the conduct of the clinical study and the determination of the results of the study.

Design outcomes

Primary

MeasureTime frame
Relapse-free Survival;

Secondary

MeasureTime frame
2yaer's Survival Rate;Overall Survival;safety profile;

Countries

China

Contacts

Public ContactMengyuan Wang

Chongqing Three Gorges Central Hospital

742676160@qq.com+86 183 6063 8689

Outcome results

None listed

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