NCT03497702

Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer

Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: Female
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.

Detailed description

STUDY RATIONALE: Patients with ER+/HER2- operable breast cancers who are candiate of neoadjuant chemotherapy generally receive chemotherapy alone before operation, followed by adjuvant endocrine therapy. Because endocrine therapy is primarily delivered in the postoperative setting, the ability to add the efficacy of aromatase inhibitors combined with chemotherapy is lost. This study offers the unique opportunity to assess the synergistic or additive responsiveness of breast tumors to endocrine therapy plus chemotherapy while the tumors are still in vivo by treating patients with an aromatast inhibitor combined with chemotherapy before surgery and assessing pCR rates. PRIMARY OBJECTIVE: The primary objective is to determine the frequency of pCR in breast and axilla.

Conditions

• Breast Cancer
• Invasive Breast Cancer

Interventions

Type	Name	Description
DRUG	Doxorubicin	60mg/m2 IV every 3 weeks for 4 cycles
DRUG	Cyclophosphamide	600mg/m2 IV every 3 weeks for 4 cycles
DRUG	Docetaxel	75mg/m2 IV every 3 weeks for 4 cycles
DRUG	Letrozole	2.5 mg once daily preoperably
DRUG	leuprorelin	3.75 mg SC every 4 weeks for premenopausal patients

Timeline

• Start date: 2017-05-08
• Primary completion: 2023-11-01
• Completion: 2024-01-01
• First posted: 2018-04-13
• Last updated: 2018-04-13

Locations

1 site across 1 country: South Korea