Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer

NCT02980965 | Completed Phase 3 DMC

• 1 other identifier: NCET-trial
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

This was an open-label, randomized controlled trial that aims to compare the efficacy and safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant chemotherapy alone in ER-positive, HER2-negative breast cancer.

Conditions

Breast Cancer Female

Keywords

breast cancer; neoadjuvant chemotherapy; endocrine therapy; concurrent

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  the proportion of patients achieving clinical complete response and partial response in the breast based on magnetic resonance imaging

  4 years

Secondary Outcomes (5)

• Ki67 proliferation marker changes

  4 years

• pathologic complete response (pCR)

  4 years

• pathological response rate

  4 years

• Progression-free survival (DFS)

  6 years

• Incidence of Serious Treatment-Emergent Adverse Events(grade 3 or 4)

  4 years

Study Arms (2)

neoadjuvant chemo-endocrine therapy

EXPERIMENTAL

In the experimental arm, patients received concurrent chemotherapy (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles) with endocrine therapy (letrozole with or without leuprorelin) as a neoadjuvant treatment

Drug: letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel

neoadjuvant chemotherapy alone

ACTIVE COMPARATOR

In the control group, patients received neoadjuvant chemotherapy alone (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles)

Drug: fluorouracil, epirubicin, cyclophosphamide, docetaxel

Interventions

letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel DRUG

Postmenopausal patients were treated with letrozole 2.5mg/day p.o until complement of neoadjuvant chemotherapy before surgery, while premenopausal ones received letrozole 2.5mg/day p.o and a subcutaneous injection of the GnRH-a, leuprorelin, as concomitant treatment with neoadjuvant chemotherapy (fluorouracil 600mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 80mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles), letrozole was delivered after 1 week of first dose of leuprorelin injection.

Also known as: GnRH-a, ENANTONE

neoadjuvant chemo-endocrine therapy

fluorouracil, epirubicin, cyclophosphamide, docetaxel DRUG

Patients received fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles.

neoadjuvant chemotherapy alone

Eligibility Criteria

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

You may qualify if:

• Estrogen receptor-positive and HER2-negative breast cancer patients, with histological stage of IIa-IIIc.
• Without previous chemotherapy or endocrine therapy.
• ECOG scores of 0-2 points
• With measurable and evaluable breast tumor pathologically confirmed as invasive ductal carcinoma
• Age: 18-70 years
• Lateral breast cancer
• Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions

You may not qualify if:

• Pregnant women or nursing mothers
• With distant metastasis
• With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, in situ cervical cancer or other cured malignant tumor without the basis of recurrence for at least five years
• With mental illness or other conditions affecting the patient compliance
• With other serious diseases or medical conditions:
• Congestive heart failure or unstable angina pectoris, myocardial infarction within 6 months before the enrollment, uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator
• Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases may affect the understanding and sign of the informed consent for
• Uncontrolled acute infection
• Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study
• With allergic constitution and any known or suspected drug allergy
• Not suitable for the trial considered by the investigator

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer Hospital/ Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Leuprolide; Fluorouracil; Epirubicin; Cyclophosphamide; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; 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; Uracil; Pyrimidinones; Pyrimidines; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Zhi-Min Shao, MD

  Cancer Hospital/ Institute, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Surgical Oncology,Cancer Hospital & Institute

Study Record Dates

• First Submitted: November 26, 2016
• First Posted: December 2, 2016
• Study Start: May 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

CN (1)