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Palbociclib combined with letrozole versus epirubicin combined with cyclophosphamide and sequential docetaxel as neoadjuvant chemotherapy for inoperable postmenopausal estrogen receptor-positive breast cancer with low Ki67 expression: a prospective randomized controlled double-blind phase IV trial

Palbociclib combined with letrozole versus epirubicin combined with cyclophosphamide and sequential docetaxel as neoadjuvant chemotherapy for inoperable postmenopausal estrogen receptor-positive breast cancer with low Ki67 expression: a prospective randomized controlled double-blind phase IV trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026493
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

Group 1:palbociclib combined with letrozole
Group 2:epirubicin combined with cyclophosphamide and sequential docetaxel

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. pathological examination confirms estrogen receptor positive, and Ki67 =T3, or lymph node stage >=N2, or ipsilateral upper extremity edema or the extent of lesions exceeds the scope of radical surgery; 4. Karnofsky functional status score >=70; 5. normal findings of blood examination, normal liver and kidney functions, and basically normal electrocardiogram results before chemotherapy; 6. aged 18–70 years old.

Exclusion criteria

Exclusion criteria: 1. history of anti-tumor treatment; 2. inflammatory breast cancer or occult breast cancer; 3. stage IV breast cancer; 4. history of other malignant tumors; 5. severe vital organ dysfunction, such as heart, liver and kidney or poor constitution cannot tolerate chemotherapy, or the treatment plan change due to intolerance during chemotherapy; 6. cannot comply with the treatment because of mental and neurological diseases; 7. dexamethasone contraindications or severe allergies to any drug in NAC; 8. receiving NAC, but it is judged to be ineffective after two cycles of treatment, and other programs are forced to be used or chemotherapy is stopped to receive surgery; 9. participation in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Efficacy;

Secondary

MeasureTime frame
Breast-conserving rate;Operable rate;Ki67 expression in tumor tissues;Miller-Payne grading system;Preoperative endocrine prognostic index;Progression-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