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

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ClinicalTrials.gov Identifier: NCT03497702
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Keun Seok Lee, National Cancer Center, Korea

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

Condition or disease Intervention/treatment Phase
Breast Cancer Invasive Breast Cancer Drug: Doxorubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Letrozole Drug: leuprorelin Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. pathologic complete remission (pCR) [ Time Frame: within 6 weeks following the last dose of chemotherapy ]
    pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 [MD Anderson definition])


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: during 6 months of neoadjuvant chemotherapy ]
    Frequency and severity of hematological and non-hematological adverse events and laboratory abnormalities according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  2. Response rate [ Time Frame: during 6 months of neoadjuvant chemotherapy ]
    Overall objective clinical response rate = CR + PR rate, measured by MRI (or US) and assessed by RECIST criteria.

  3. Downstaging to breast conserving surgery (BCS) [ Time Frame: within 6 weeks following the last dose of chemotherapy ]
    Ratio of the number of patients with breast conserving surgery converted from planned mastectomy over the number of patients with initially planned mastectomy

  4. Disease free survival [ Time Frame: Patients will be followed up to 6 years ]
    Disease-free survival (DFS) following operation.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497702


Contacts
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Contact: Keun Seok Lee, MD, PhD +82-31-920-1220 kslee@ncc.re.kr

Locations
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Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Korea, Republic of
Contact: Keun Seok Lee, MD, PhD         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
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Principal Investigator: Keun Seok Lee, MD, PhD National Cancer Center

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Responsible Party: Keun Seok Lee, Head, Center for Breast Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT03497702     History of Changes
Other Study ID Numbers: NCC2017-0110
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
Liposomal doxorubicin
Letrozole
Estrogens
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists