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A Randomized, Multi-Centre, Open-Label Study of Neo-adjuvant Taxanes and Capecitabine(TX) versus Taxanes and Anthracycline(TA) for Breast Cancer

A Randomized, Multi-Centre, Open-Label Study: Comparision of the efficacy and safety of Neo-adjuvant Taxanes and Capecitabine(TX) versus Taxanes and Anthracycline(TA) in Patients with Breast Cancer

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000206729
Enrollment
166
Registered
2013-02-21
Start date
2012-08-24
Completion date
2018-12-29
Last updated
2022-10-10

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

Conditions

None listed

Brief summary

This is a randomized clinical trial comparing combination of taxanes and capecitabine (TX) versus the combination of taxanes and anthracycline (TA) in neoadjuvant setting in patients with stage II-III breast cancer. The first end point is treatment response (pCR rate). And the adverse effect related to the preoperative cytotoxic therapy is assessed.

Interventions

The patients with breast cancer are randomly assigned to one of two groups, receiving taxanes and capecitabine(TX) or taxanes and anthracycline(TA) regimen in neoadjuvant setting. The treatment response would be evaluated after the completion of two cycles. In compelte response , partial response, and stable patients, the therapy will be continued to four cycles , but patients with progressive lesions will be excluded(individualized therapy will be considered). After four cycle chemotherapy, su

The patients with breast cancer are randomly assigned to one of two groups, receiving taxanes and capecitabine(TX) or taxanes and anthracycline(TA) regimen in neoadjuvant setting. The treatment response would be evaluated after the completion of two cycles. In compelte response , partial response, and stable patients, the therapy will be continued to four cycles , but patients with progressive lesions will be excluded(individualized therapy will be considered). After four cycle chemotherapy, surgery will be carried out and pathological response will be assessed. The specific surgery type, breast conserving surgery or modified radical mastectomy, will be dependent on individual patient. 1. TX arm: paclitaxel 175mg/m2, or docetaxel 75 mg/m2, introvenous, once every 3 weeks, combined with Capecitabine 1000mg/m2, oral, twice every day for 14 days,every 3 weeks. 2. TA arm: paclitaxel 175mg/m2, or docetaxel 75 mg/m2, introvenous, once every 3 weeks, combined with epirubicin 75mg/m2, introvenous, once every 3 weeks.

Sponsors

Peking University People's Hospital Breast Center
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1.Histological comfirmed breast cancer 2.Non-special type breast cancer 2.With at least one measurable lesion 3.Without distant metastasis

Exclusion criteria

1.Without any contradiction of chemotherapy or the drug concerned 2.ECOG score > 1 3.No systemic anti-cancer therapy before

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026