PemVin vs Vin in Previously Treated Metastatic Breast Cancer

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03242616
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34.4
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: Pemetrexed + Vinorelbine; Drug: Vinorelbine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 17, 2017
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pemetrexed + Vinorelbine 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	Drug: Pemetrexed + Vinorelbine; Vinorelbine (25 mg/m2, day 1 & 8) Pemetrexed (500 mg/m2, day 1)
Active Comparator: Vinorelbine Vinorelbine (25 mg/m2, day 1 & 8)	Drug: Vinorelbine; Vinorelbine (25 mg/m2, day 1 & 8)

Outcome Measures

Primary Outcome Measures

1. progression free survival [response assessment every 6 weeks, for up to 2 years]

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

Secondary Outcome Measures

1. response rate [response assessment every 6 weeks, for up to 2 years]

   Proportion of patients with objective response by RECIST version 1.1

2. duration of response [response assessment every 6 weeks, for up to 2 years]

   Time from documentation of tumor response to disease progression

3. overall survival [up to 2 years]

   From date of first dose of study drug till the date of death from any cause

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seock-Ah Im, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03242616
• Other Study ID Numbers: H1607-172-780
• First Posted: Aug 8, 2017
• Last Update Posted: Aug 8, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Pemetrexed; Vinorelbine

Study Results

No Results Posted as of Aug 8, 2017