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Completed

NCT Number: NCT02980965

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

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.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Hospital/ Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

Data showed that concurrent neoadjuvant chemotherapy with endocrine therapy was a effective option for ER-positive, HER2-negative breast cancer patients. However this is still a controversial issue. The present study is an open-label randomized controlled clinical trial that aims to investigate the efficacy of concurrent NCT with endocrine therapy (AI with or without GnRH-a) in patients with ER-positive, HER2-negative breast carcinoma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: GnRH-a, ENANTONE

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.

Primary outcomes

  1. objective response rate (ORR)

    Time frame: 4 years

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

Secondary outcomes

  1. Ki67 proliferation marker changes

    Time frame: 4 years

    Absolute Ki67 change as well as geometric mean percentage change in Ki67 positivity

  2. pathologic complete response (pCR)

    Time frame: 4 years

    Disappearance of residual invasive disease (residual ductal carcinoma in situ allowed) in breast and the absence of positive lymph nodes

  3. pathological response rate

    Time frame: 4 years

    The proportion of patients achieving pathological response based on Miller-Payne grading system

  4. Progression-free survival (DFS)

    Time frame: 6 years

    The interval between the date of randomization to disease progression during treatment, any recurrence, contralateral breast cancer, the appearance of a second primary cancer, or death not due to cancer, whichever occurred first.

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

    Time frame: 4 years

    Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Randomized Controlled Study to Evaluate the Efficacy and Safety of Endocrine Therapy Plus Chemotherapy Versus Chemotherapy Alone as the Neoadjuvant Therapy in the Treatment of ER-positive, HER2-negative Breast Cancer (IIa-IIIc)

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2016
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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