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

NCT03497702 | Unknown Phase 2

• 1 other identifier: NCC2017-0110
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Invasive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• pathologic complete remission (pCR)

  pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 \[MD Anderson definition\])

  within 6 weeks following the last dose of chemotherapy

Secondary Outcomes (4)

• Adverse events

  during 6 months of neoadjuvant chemotherapy

• Response rate

  during 6 months of neoadjuvant chemotherapy

• Downstaging to breast conserving surgery (BCS)

  within 6 weeks following the last dose of chemotherapy

• Disease free survival

  Patients will be followed up to 6 years

Study Arms (1)

Experimental

EXPERIMENTAL

Patients receive neoadjuvant chemotherapy (doxorubicin 60mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 every 3 weeks for 4 cycles followed by docetaxel 75mg/m2 IV on day 1 every 3 weeks for 4 cycles) plus letrozole with or without leuproelin depending on menopausal status

Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Letrozole; Drug: leuprorelin

Interventions

Doxorubicin DRUG

60mg/m2 IV every 3 weeks for 4 cycles

Experimental

Cyclophosphamide DRUG

600mg/m2 IV every 3 weeks for 4 cycles

Experimental

Docetaxel DRUG

75mg/m2 IV every 3 weeks for 4 cycles

Experimental

Letrozole DRUG

2.5 mg once daily preoperably

Experimental

leuprorelin DRUG

3.75 mg SC every 4 weeks for premenopausal patients

Experimental

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven breast cancer patients who are candidate of neoadjuvant chemotherapy with AC followed by Docetaxel
• Age: 19-70 years
• ER or PR positive ,cT2-3N0 or cT1-3/N+ M0 (ER-positive ≥1% nuclear staining by immunohistochemistry , Allred score≥3 )
• Available FFPE tissue for biomarker study
• HER2-negative by ASCO/CAP guideline
• Patients who agree to adequate contraception
• ECOG scores of 0-2
• Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions
• Patients who provide consent

You may not qualify if:

• Inflammatory breast cancer
• Distant metastasis
• Cerebral vascular accidents including transient ischemic attack
• Pulmanary thromboembolism or deep vein thrombosis with 6 months; however, patients who received more than 6 weeks of anticoagulation within 6 months and remains asymptomatic are eligible.
• With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, curatively resected early gastric cancer, differentiated thyoid cancer \< 1 cm, or other cured malignant tumor without recurrence for at least 3 years
• Ejection Fraction \<55% by MUGA scan / Echo CG
• No available tissue for biomarker study
• Pregnant or lactating women
• Patients with other serious diseases or medical conditions: Pituitary adenoma, Malabsorption syndrome, Major resection of gastrointestinal tract, Corrected QT interval \> 480 msec, Congestive heart failure or unstable angina pectoris, myocardial infarction, stent insertion, angioplasty, coronary bypass surgery, symptomatic peripheral artery disease within 6 months before the enrollment
• NYHA class III or IV congestive heart failure
• Uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator
• Major surgery, major trauma, and/or unhealed wound, fracture, or ulcer within 4 weeks
• Acute hemorrhage or hemorrhagic tendency
• Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases which may affect the understanding and sign of the informed consent
• Uncontrolled acute infection

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; Cyclophosphamide; Docetaxel; Letrozole; Leuprolide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Keun Seok Lee, MD, PhD

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keun Seok Lee, MD, PhD

CONTACT

+82-31-920-1220; kslee@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Center for Breast Cancer

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: April 13, 2018
• Study Start: May 8, 2017
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

KR (1)