PemVin vs Vin in Previously Treated Metastatic Breast Cancer

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03242616
• Other study ID #: H1607-172-780
• Status: Recruiting
• Phase: Phase 2
• First received: July 28, 2017
• Last updated: August 3, 2017
• Start date: February 17, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2017
• Source: Seoul National University Hospital
• Contact: Seock-Ah Im
• Phone: 82-2-2072-0850
• Email: moisa[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Pemetrexed + Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8) Pemetrexed (500 mg/m2, day 1)
• Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	From date of first dose of study drug till the date of documented progression or death from any cause	response assessment every 6 weeks, for up to 2 years
Secondary	response rate	Proportion of patients with objective response by RECIST version 1.1	response assessment every 6 weeks, for up to 2 years
Secondary	duration of response	Time from documentation of tumor response to disease progression	response assessment every 6 weeks, for up to 2 years
Secondary	overall survival	From date of first dose of study drug till the date of death from any cause	up to 2 years