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Eribulin Plus Gemcitabine (EG) vs Paclitaxel Plus Gemcitabine (PG) in HER2-Negative Metastatic Breast Cancer (EG_PG)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Eisai Inc.
Dong-A ST Co., Ltd.
Samyang Biopharmaceuticals Corporation
Information provided by (Responsible Party):
Kyung Hae Jung, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT02263495
First received: October 6, 2014
Last updated: April 6, 2017
Last verified: April 2017
  Purpose

Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective chemotherapy. Paclitaxel plus Gemcitabine (PG) combination chemotherapy is one of the preferred chemotherapeutic regimens for patients with MBC, and was found to be proper as a maintenance chemotherapy regimen with survival benefit and feasible toxicity profile as shown in a large phase III KCSG (Korean Cancer Study Group) study (Park Y et al. J Clin Oncol 31(14):1732, 2013).

Eribulin mesylate is a microtubule-targeting agent that showed improved overall survival benefit as monotherapy for MBC patients as a new chemotherapeutic agent after failure of anthracycline and taxane in EMBRACE study (Cortes J et. al. Lancet 377:914-923, 2011). Eribulin was also reported its promising efficacy in another randomized phase III study that demonstrated eribulin as efficacious as capecitabine (Kaufman P et. al. Abstr# S6-6, SABCS 2012). Both study results showed potential clinical benefit in patients with triple negative MBC (TNBC). Thus, eribulin combined with gemcitabine may be a new potential regimen for early line therapy in patients with metastatic breast cancer.

Furthermore, eribulin may have rational benefit compared with paclitaxel in terms of neurotoxicity. Although there is no direct evidence that eribulin has better neurotoxicity profile than taxane, eribulin tended to show less neurotoxicity compared with ixabepilone in a phase II trial (Vahdat, L et al. 2011 SABCS). Eribulin has no worsen toxicity as compared to paclitaxel. Therefore, EG may have less neurotoxicity comparing to PG.

In phase I trial, eribulin in combination with gemcitabine was feasible in patients with advanced solid tumor treated with chemotherapy (< 3 lines) (Goel R, et al, 2009 ASCO).

Based on this rationale, the investigators are to conduct randomized phase II study comparing EG chemotherapy with PG chemotherapy for patients with HER-2 negative MBC as first-line chemotherapy.

A total of 112 patients will be recruited. Patients will be randomized to a treatment arm by permutated method. The randomization ratio is 1:1. This study is multi-center, randomized, open label study.


Condition Intervention Phase
Metastatic Breast Cancer Drug: Paclitaxel Drug: Eribulin Drug: Gemcitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized Trial of Eribulin Plus Gemcitabine (EG) vs.Paclitaxel Plus Gemcitabine (PG) in Patients With HER2-Negative Metastatic Breast Cancer as First -Line Chemotherapy

Resource links provided by NLM:


Further study details as provided by Kyung Hae Jung, Asan Medical Center:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 48months ]
    To demonstrate that EG is not inferior to PG group in terms of PFS in patients with metastatic or recurrent breast cancer as first-line treatment.


Secondary Outcome Measures:
  • overall survival [ Time Frame: 48months ]
    Survival will be measured as the time from randomization to the date of death.

  • neuropathic scale [ Time Frame: expected at 9week , expected at 24week ]
    FACT for Taxane QOL assessment

  • toxicity [ Time Frame: from first administration until 28 days after the last dose administration ]
    Using CTCAE Version 4.0

  • duration of response [ Time Frame: 48months ]
    using RECIEST version 1.1

  • objective response rate [ Time Frame: 48months ]
    using RECIEST version 1.1

  • clinical benefit rate [ Time Frame: 48months ]

Enrollment: 118
Study Start Date: November 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paclitaxel & Gemcitabine(PG)
Paclitaxel 175mg/m2 IV , Day1,every 3weeks Gemcitabine 1250mg/m2 IV ,Day1& Day8 every 3weeks
Drug: Paclitaxel
175mg/m2 + D5W 500mL MIV over 3hrs before gemcitabine administration
Other Name: Genexol,
Drug: Gemcitabine
PG:1250mg/m2 + NS 100ml MIV over 30mins EG:1000mg/m2 + NS 100ml MIV over 30mins
Other Name: Gemcit
Experimental: Eribulin & Gemcitabine(EG)
Eribulin 1.0 mg/m2, 2-5min iv ,Day1& Day8 every 3weeks Gemcitabine 1,000 mg/m2 ,Day1& Day8 every 3weeks
Drug: Eribulin
1.0 mg/m2, 2-5min iv before gemcitabine (or miv with NS 100ml in max.)
Other Name: Halaven,
Drug: Gemcitabine
PG:1250mg/m2 + NS 100ml MIV over 30mins EG:1000mg/m2 + NS 100ml MIV over 30mins
Other Name: Gemcit

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed metastatic, or recurrent breast cancer
  2. HER2-negative breast cancer
  3. age > 18 years
  4. ECOG performance status 0 - 2
  5. Pre- or postmenopausal breast cancer patients with measurable or non-measurable lesions, who are candidates for chemotherapy
  6. Life expectancy ≥ 3 months
  7. No prior history of chemotherapy for metastatic, recurrent breast cancer
  8. Patients may have received prior neoadjuvant or adjuvant taxane regimen as long as it has been 12 months since completion of regimen.
  9. Patients either may or may not have a prior anthracycline containing regimen.
  10. Prior hormonal therapy as a treatment of metastatic disease is allowed. But antitumoral hormonal therapy must be terminated prior to enrollment(up to the date of randomization)
  11. Prior radiation therapy allowed as long as < 25% of the bone marrow has been treated, and the patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed 2 weeks before study entry.
  12. Bisphosphonates for the treatment of bone metastases should not be initiated following the first dose of randomized therapy. It must be initiated prior to day of treatment (cycle 1, day 1). Patients may continue on bisphosphonates who already established on bisphosphonate therapy for bone metastases
  13. Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
  14. Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
  15. Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST & ALTX3 upper normal limit or AST and ALT ≤ 5.0XULN if judged by the investigator to be related to liver metastases)
  16. Written informed consent

Exclusion Criteria:

  1. Serious uncontrolled intercurrent infections
  2. Serious intercurrent medical or psychiatric illness, including active cardiac disease
  3. Pregnancy or breast feeding
  4. Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
  5. Documented parenchymal or leptomeningeal brain metastasis
  6. Peripheral neuropathy ≥ grade 2
  7. Prior treatment with gemcitabine will not be allowed.
  8. HER-2 overexpressing breast cancer and concomitant trastuzumab treatment is not allowed
  9. Women of childbearing potential, unwilling to use a medically acceptable method of contraception during the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02263495

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Eisai Inc.
Dong-A ST Co., Ltd.
Samyang Biopharmaceuticals Corporation
Investigators
Principal Investigator: Kyung Hae Jung, Dr Asan Medical Center
  More Information

Responsible Party: Kyung Hae Jung, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02263495     History of Changes
Other Study ID Numbers: 2014-0857
Study First Received: October 6, 2014
Last Updated: April 6, 2017

Keywords provided by Kyung Hae Jung, Asan Medical Center:
HER2-Negative

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017