Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy

• Status: Not yet recruiting
• Trial end date: 2026-05-31
• Target enrollment: 0
• Participant gender: Female

Summary

With the development of neoadjuvant therapy for tumors, neoadjuvant chemotherapy (NAC) has become one of the most common and effective methods for preoperative systemic treatment of locally advanced breast cancer (LABC). Although epirubicin combined with cyclophosphamide and sequential docetaxel has been widely recognized as the first-line NAC for LABC, there are still some inoperable LABCs that are insensitive to chemotherapy and miss the opportunity of surgery, especially those with luminal A and low expression of Ki67. Therefore, neoadjuvant endocrine therapy has important clinical value for such patients. At present, the combination of aromatase inhibitor drugs and cyclin dependent kinase 4/6 can significantly improve the prognosis and survival of LABC compared with aromatase inhibitor monotherapy. However, whether inoperable LABC patients, especially those who are not susceptible to chemotherapy, can choose the combination of aromatase inhibitor drugs and cyclin dependent kinase 4/6 as neoadjuvant endocrine therapy to replace NAC remains unclear. Because the main principle of endocrine therapy is to induce tumor cell cycle arrest, leading to apoptosis of tumor cells, the effect is slower than that of chemotherapy. In addition, whether endocrine therapy can replace chemotherapy as a new adjuvant treatment for patients with inoperable LABC to improve the operability rate has not yet been fully evidenced. Therefore, this trial aims to conduct the prospective randomized controlled phase IV clinical trial of palbociclib combined with letrozole versus epirubicin combined with cyclophosphamide and sequential docetaxel as NAC to prove the efficacy of palbociclib combined with letrozole in postmenopausal estrogen receptor-positive LABC patients with low Ki67 expression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shengjing Hospital
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin; Estrogens; Letrozole; Palbociclib

Criteria

Inclusion Criteria:

• pathological examination confirms estrogen receptor positive, and Ki67 < 30% in breast cancer patients;

• postmenopausal women;

• tumor size stage ≥ T3, or lymph node stage ≥ N2, or ipsilateral upper extremity edema or the extent of lesions exceeds the scope of radical surgery;

• Karnofsky functional status score ≥ 70;

• normal findings of blood examination, normal liver and kidney functions, and basically normal electrocardiogram results before chemotherapy;

• age range from 18-70 years old.

Exclusion Criteria:

• history of anti-tumor treatment;

• inflammatory breast cancer or occult breast cancer;

• stage IV breast cancer;

• history of other malignant tumors;

• 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;

• cannot comply with the treatment because of mental and neurological diseases;

• dexamethasone contraindications or severe allergies to any drug in NAC;

• 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;

• participation in other clinical trials.