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PemVin vs Vin in Previously Treated Metastatic Breast Cancer

Primary Purpose

Breast Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pemetrexed + Vinorelbine
Vinorelbine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. histologically confirmed, recurrent or metastatic breast cancer
  2. HER2-negative
  3. ECOG PS 0-2
  4. Age ≥ 20 years
  5. Anthracycline- and Taxane-pretreated
  6. Wash-out period of 3 weeks for cytotoxic chemotherapy
  7. Wash-out period of 2 weeks for hormone therapy or radiotherapy
  8. measurable or non-measurable lesions by RECIST v1.1
  9. Adequate hematological functions : ANC ≥1,500/mm3, Platelet ≥100,000/mm3, Hb≥ 9g/dL
  10. Adequate liver functions
  11. Adequate renal functions : sCr≤1.5mg/dL
  12. Subjects willing to follow study protocol
  13. Informed consent before study entry

Exclusion Criteria:

  1. More than 3 lines of chemotherapy for metastatic breast cancer
  2. Pregnant or breastfeeding women
  3. Previous exposure to Pemetrexed or Vinorelbine
  4. Neuropathy (grade 2 or more)
  5. Symptomatic CNS metastasis
  6. History of malignant disease within 5 years (except for cured basal cell cancer or squamous cell cancer of skin, cured thyroid cancer, in-situ cervical cancer)
  7. Hypersensitivity to study medication or related drugs
  8. Concomitant vaccination for yellow fever

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pemetrexed + Vinorelbine

Vinorelbine

Arm Description

Vinorelbine (25 mg/m2, day 1 & 8) Pemetrexed (500 mg/m2, day 1) Actinamide 1mg IM: 1 week before 1st dose, q 9 weeks (1wk before 1st cycle, 4th,7th,10th…. cycle after then.) Folic acid 1mg daily: 1 week before 1st dose until 3 weeks after last dose Dexa 4mg po bid on D0-2

Vinorelbine (25 mg/m2, day 1 & 8)

Outcomes

Primary Outcome Measures

progression free survival
From date of first dose of study drug till the date of documented progression or death from any cause

Secondary Outcome Measures

response rate
Proportion of patients with objective response by RECIST version 1.1
duration of response
Time from documentation of tumor response to disease progression
overall survival
From date of first dose of study drug till the date of death from any cause

Full Information

First Posted
July 28, 2017
Last Updated
August 3, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03242616
Brief Title
PemVin vs Vin in Previously Treated Metastatic Breast Cancer
Official Title
Randomized Phase II Trial of Pemetrexed Plus Vinorelbine Versus Vinorelbine in Patients With Recurrent or Metastatic Breast Cancer Previously Treated With or Resistant to Anthracycline and Taxane
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these are largely done before the wide use of premedication (steroid and vitamin B12) for pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer. This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in patients with recurrent or metastatic breast cancer previously treated with or resistant to an anthracycline and taxane.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pemetrexed + Vinorelbine
Arm Type
Experimental
Arm Description
Vinorelbine (25 mg/m2, day 1 & 8) Pemetrexed (500 mg/m2, day 1) Actinamide 1mg IM: 1 week before 1st dose, q 9 weeks (1wk before 1st cycle, 4th,7th,10th…. cycle after then.) Folic acid 1mg daily: 1 week before 1st dose until 3 weeks after last dose Dexa 4mg po bid on D0-2
Arm Title
Vinorelbine
Arm Type
Active Comparator
Arm Description
Vinorelbine (25 mg/m2, day 1 & 8)
Intervention Type
Drug
Intervention Name(s)
Pemetrexed + Vinorelbine
Intervention Description
Vinorelbine (25 mg/m2, day 1 & 8) Pemetrexed (500 mg/m2, day 1)
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
Vinorelbine (25 mg/m2, day 1 & 8)
Primary Outcome Measure Information:
Title
progression free survival
Description
From date of first dose of study drug till the date of documented progression or death from any cause
Time Frame
response assessment every 6 weeks, for up to 2 years
Secondary Outcome Measure Information:
Title
response rate
Description
Proportion of patients with objective response by RECIST version 1.1
Time Frame
response assessment every 6 weeks, for up to 2 years
Title
duration of response
Description
Time from documentation of tumor response to disease progression
Time Frame
response assessment every 6 weeks, for up to 2 years
Title
overall survival
Description
From date of first dose of study drug till the date of death from any cause
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically confirmed, recurrent or metastatic breast cancer HER2-negative ECOG PS 0-2 Age ≥ 20 years Anthracycline- and Taxane-pretreated Wash-out period of 3 weeks for cytotoxic chemotherapy Wash-out period of 2 weeks for hormone therapy or radiotherapy measurable or non-measurable lesions by RECIST v1.1 Adequate hematological functions : ANC ≥1,500/mm3, Platelet ≥100,000/mm3, Hb≥ 9g/dL Adequate liver functions Adequate renal functions : sCr≤1.5mg/dL Subjects willing to follow study protocol Informed consent before study entry Exclusion Criteria: More than 3 lines of chemotherapy for metastatic breast cancer Pregnant or breastfeeding women Previous exposure to Pemetrexed or Vinorelbine Neuropathy (grade 2 or more) Symptomatic CNS metastasis History of malignant disease within 5 years (except for cured basal cell cancer or squamous cell cancer of skin, cured thyroid cancer, in-situ cervical cancer) Hypersensitivity to study medication or related drugs Concomitant vaccination for yellow fever
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seock-Ah Im
Phone
82-2-2072-0850
Email
moisa@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung-Hun Lee
Phone
82-2-2072-7207
Email
kyunghunlee@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seock-Ah Im
Phone
82-2-2072-0850
Email
moisa@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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PemVin vs Vin in Previously Treated Metastatic Breast Cancer

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