Description:
This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.
Clinical Trials /
Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
NCT03497702
Related Conditions:
- Breast Carcinoma
Recruiting Status:
Recruiting
Phase:
Phase 2
Trial Eligibility
Document
Title
- Brief Title: Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
- Official Title: Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
Clinical Trial IDs
- ORG STUDY ID: NCC2017-0110
- NCT ID: NCT03497702
Conditions
- Breast Cancer
- Invasive Breast Cancer
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| Doxorubicin | Experimental | |
| Cyclophosphamide | Experimental | |
| Docetaxel | Experimental | |
| Letrozole | Experimental | |
| leuprorelin | Experimental |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| 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 |
|
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patients with allergic constitution and any known or suspected drug allergy
- Concurrent use of other investigational drugs; or participating in other clinical
trials involving investigational drugs within 30 days before this study
- Patients with mental illness or other conditions affecting the patient compliance
- Not suitable for the trial considered by the investigator
| Maximum Eligible Age: | 70 Years |
| Minimum Eligible Age: | 19 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | pathologic complete remission (pCR) |
| Time Frame: | within 6 weeks following the last dose of chemotherapy |
| Safety Issue: | |
| Description: | pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 [MD Anderson definition]) |
Secondary Outcome Measures
| Measure: | Adverse events |
| Time Frame: | during 6 months of neoadjuvant chemotherapy |
| Safety Issue: | |
| Description: | Frequency and severity of hematological and non-hematological adverse events and laboratory abnormalities according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0 |
| Measure: | Response rate |
| Time Frame: | during 6 months of neoadjuvant chemotherapy |
| Safety Issue: | |
| Description: | Overall objective clinical response rate = CR + PR rate, measured by MRI (or US) and assessed by RECIST criteria. |
| Measure: | Downstaging to breast conserving surgery (BCS) |
| Time Frame: | within 6 weeks following the last dose of chemotherapy |
| Safety Issue: | |
| Description: | Ratio of the number of patients with breast conserving surgery converted from planned mastectomy over the number of patients with initially planned mastectomy |
| Measure: | Disease free survival |
| Time Frame: | Patients will be followed up to 6 years |
| Safety Issue: | |
| Description: | Disease-free survival (DFS) following operation. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | National Cancer Center, Korea |
Last Updated
April 13, 2018
