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Metastatic Breast CancerPhase 2EG_PGNCT02263495

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

A Phase 2 study testing Paclitaxel, Eribulin and Gemcitabine in people with Metastatic Breast Cancer, run by Asan Medical Center at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Paclitaxel, Eribulin and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
2 sitesSouth Korea
Study dates
19 Dec 2014to 17 Jun 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed metastatic, or recurrent breast cancer
  • HER2-negative breast cancer
  • age > 18 years
  • ECOG performance status 0 - 2
  • Pre- or postmenopausal breast cancer patients with measurable or non-measurable lesions, who are candidates for chemotherapy
  • Life expectancy ≥ 3 months
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  • No prior history of chemotherapy for metastatic, recurrent breast cancer
  • Patients may have received prior neoadjuvant or adjuvant taxane regimen as long as it has been 12 months since completion of regimen.
  • Patients either may or may not have a prior anthracycline containing regimen.
  • 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)
  • 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.
  • 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
  • Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
  • Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
  • 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)
  • Written informed consent

Who cannot join

  • Serious uncontrolled intercurrent infections
  • Serious intercurrent medical or psychiatric illness, including active cardiac disease
  • Pregnancy or breast feeding
  • 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)
  • Documented parenchymal or leptomeningeal brain metastasis
  • Peripheral neuropathy ≥ grade 2
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  • Prior treatment with gemcitabine will not be allowed.
  • HER-2 overexpressing breast cancer and concomitant trastuzumab treatment is not allowed
  • Women of childbearing potential, unwilling to use a medically acceptable method of contraception during the trial

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

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

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.

Read more

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 118 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.

Read the detailed description

A total of enrolled 118 patients in EG and PG groups, will be provided chemotherapy regimen:

Paclitaxel/Gemcitabine (PG) : every 3 weeks D1 Paclitaxel 175mg/m2 + D5W 500mL MIV over 3hrs before gemcitabine administration D1, D8 Gemcitabine 1,250 mg/m2 + NormalSaline 100ml MIV over 30mins

  • Pre \& Post medication (which can be changed according to institutions' policy) D1 Corticosteroid 100 mg i.v. 30 min. before Paclitaxel Pheniramine 1A + D5W 50mL MIV 30mins before Paclitaxel Ranitidine 50mg IV + D5W 50mL MIV 30mins before Paclitaxel HT3 antagonist 1A + D5W 50 mL MIV 30mins before Paclitaxel

Eribulin/Gemcitabine (EG): every 3weeks D1, D8 Eribulin 1.0 mg/m2, 2-5min iv before gemcitabine (or miv with NormalSaline 100ml in max.) D1, D8 Gemcitabine 1000 mg/m2 + NormalSaline100ml MIV over 30mins

<schedule of Assessment adn procedures (±3 days window period ) >

  1. screening /baseline
  • obtaining Informed consent form
  • collecting information
  • demographic data
  • breast cancer treatment history/ medical history
  • general physical examination/ vital sign \& Performance status
  • Test: CBC/blood chemistry/ Tumor response(CT or MRI)/
  • collecting QOL questionnaire using FACT-Taxane
  1. cycle 1 ~ prior to EOT
  • general physical examination/ vital sign \& Performance status
  • Test: CBC/blood chemistry/ Tumor response(CT or MRI)
  • collecting QOL questionnaire using FACT-Taxane
  • administration PG or EG
  1. EOT(end of treatment)
  • general physical examination/ vital sign \& Performance status
  • Test: CBC/blood chemistry/ Tumor response(CT or MRI)
  • collecting QOL questionnaire using FACT-Taxane
  1. survival follow up(every 12weeks)
  • survival
  • anti neoplastic therapy after end of treatment
  • The tumor response will be performed every 12 (±2) weeks until disease progression

<WITHDRAWAL OF SUBJECTS>

Subjects may be withdrawn from the study (i.e. from any further study medication or study procedure) for the following reasons:

  • At their own request
  • If, in the investigator's opinion, continuation in the study would be detrimental to the subject's well-being
  • In case of disease progression
  • In case of unacceptable toxicity
Being tested
Paclitaxel, Eribulin, Gemcitabine
Keywords
HER2-Negative
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Genexol,

    175mg/m2 + D5W 500mL MIV over 3hrs before gemcitabine administration

  • EribulinDrug

    Also called Halaven,

    1.0 mg/m2, 2-5min iv before gemcitabine (or miv with NS 100ml in max.)

  • GemcitabineDrug

    Also called Gemcit

    PG:1250mg/m2 + NS 100ml MIV over 30mins EG:1000mg/m2 + NS 100ml MIV over 30mins

Study groups in NCT02263495
Study groupRoleWhat they receive
Paclitaxel & Gemcitabine(PG)Active comparatorPaclitaxel 175mg/m2 IV , Day1,every 3weeks Gemcitabine 1250mg/m2 IV ,Day1\& Day8 every 3weeks
Receives: Drug: Paclitaxel; Drug: Gemcitabine
Eribulin & Gemcitabine(EG)ExperimentalEribulin 1.0 mg/m2, 2-5min iv ,Day1\& Day8 every 3weeks Gemcitabine 1,000 mg/m2 ,Day1\& Day8 every 3weeks
Receives: Drug: Eribulin; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    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.

    Measured: 48months

Secondary outcomes (6)

  1. overall survival

    Survival will be measured as the time from randomization to the date of death.

    Measured: 48months

  2. neuropathic scale

    FACT for Taxane QOL assessment

    Measured: expected at 9week , expected at 24week

  3. toxicity of study drugs

    Using CTCAE Version 4.0

    Measured: from first administration until 28 days after the last dose administration

  4. duration of response

    using RECIEST version 1.1

    Measured: 48months

  5. objective response rate

    using RECIEST version 1.1

    Measured: 48months

  6. clinical benefit rate

    using RECIEST version 1.1

    Measured: 48months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2014 (estimated)
  2. Study start19 Dec 2014
  3. Primary completion11 May 2017
  4. Study completion17 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02263495
Sponsor's protocol ID
2014-0857
Acronym
EG_PG
Status last verified
Jul 2020
First submitted
6 Oct 2014
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • Kim JY, Lee E, Park K, Im SA, Sohn J, Lee KS, Chae YS, Kim JH, Kim TY, Jung KH, Park YH; Breast Cancer Committee of the Korean Cancer Study Group. Exploratory biomarker analysis from a phase II clinical trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine for HER2-negative metastatic breast cancer patients (KCSG BR13-11). Breast Cancer Res Treat. 2019 Nov;178(2):367-377. doi: 10.1007/s10549-019-05400-y. Epub 2019 Aug 12.

    PubMed 31407230

  • Park YH, Im SA, Kim SB, Sohn JH, Lee KS, Chae YS, Lee KH, Kim JH, Im YH, Kim JY, Kim TY, Lee KH, Ahn JH, Kim GM, Park IH, Lee SJ, Han HS, Kim SH, Jung KH; Korean Cancer Study Group (KCSG). Phase II, multicentre, randomised trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy in patients with HER2-negative metastatic breast cancer. Eur J Cancer. 2017 Nov;86:385-393. doi: 10.1016/j.ejca.2017.10.002. Epub 2017 Nov 5.

    PubMed 29100193

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Eribulin and Gemcitabine in people with Metastatic Breast Cancer, run by Asan Medical Center at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 48months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02263495, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.

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