We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04489173
Previous Study | Return to List | Next Study

TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer (TIBET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04489173
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : March 4, 2022
Sponsor:
Collaborators:
Erasmus Medical Center
UMC Utrecht
Servier
BOOG Study Center
Information provided by (Responsible Party):
Borstkanker Onderzoek Groep

Tracking Information
First Submitted Date  ICMJE July 22, 2020
First Posted Date  ICMJE July 28, 2020
Last Update Posted Date March 4, 2022
Actual Study Start Date  ICMJE September 25, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
Progression-free survival [ Time Frame: 16 weeks ]
Response rate CR/PR
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
  • Adverse events [ Time Frame: every 4 weeks ]
    CTCAE version 4.0
  • QoL [ Time Frame: 32 weeks ]
    Quality of Life questionnaire EORTC QLQ-C30
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer
Official Title  ICMJE A Phase 2 Study of Trifluridine/Tipiracil in Patients With ER-positive, HER2-negative Advanced Breast Cancer That Previously Received Chemotherapy
Brief Summary This is a multicenter phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
Detailed Description

Multicenter phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. This study will be conducted under the sponsorship of BOOG, Amsterdam, NL.

Objectives:

To evaluate the efficacy of trifluridine/tipiracil by determination of the percentage of patients being progression free at 8 weeks on trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced breast cancer patients previously treated with a taxane and capecitabine.

Endpoints:

Progression-free survival Response rate CR/PR at 16 weeks Adverse events Translational research on biological factors that may be of influence on the outcome of treatment QoL

Main eligibility criteria:

Metastatic Her2 negative, ER-positive breast cancer patients that progressed on, or after treatment with Capecitabine. Previous treatment with Taxanes is obligatory. Adequate hematology, liver and renal function tests.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Multicenter, single arm, phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.

Study medication should be started within 3 days after completion of screening and continue until a study treatment discontinuation criterion is met.

Trifluridine/tipiracil will be administered orally BID on days 1 through 5, with the first dose administered in the morning of day 1 of each cycle and the last dose administered in the evening of day 5, followed by a recovery period from day 6 through day 7. Trifluridine/tipiracil will be administered orally BID on days 8 through 12, with the first dose administered in the morning of day 8 of each cycle and the last dose administered in the evening of day 12, followed by a recovery period from day 13 through day 28. Each cycle will be 28 days.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasm
  • Chemotherapy Effect
Intervention  ICMJE Drug: trifluridine/tipiracil

Study medication should be started within 3 days after completion of screening and continue until a study treatment discontinuation criterion is met.

Trifluridine/tipiracil will be administered orally BID on days 1 through 5, with the first dose administered in the morning of day 1 of each cycle and the last dose administered in the evening of day 5, followed by a recovery period from day 6 through day 7. Trifluridine/tipiracil will be administered orally BID on days 8 through 12, with the first dose administered in the morning of day 8 of each cycle and the last dose administered in the evening of day 12, followed by a recovery period from day 13 through day 28. Each cycle will be 28 days.

Other Name: Lonsurf, TAS102
Study Arms  ICMJE Experimental: Treatment
Treatment with TAS102
Intervention: Drug: trifluridine/tipiracil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult women(≥ 18 years of age) with proven diagnosis of metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy
  2. Documented ER positive (10%) and/or PR positive (10%) and HER2 negative metastatic breast cancer
  3. Progressive disease based on imaging
  4. Women previously treated with capecitabine (in metastatic setting), and a maximum of two other lines of chemotherapy including a taxane either in the (neo)adjuvant or metastatic setting.
  5. Evaluable disease as defined per RECIST v.1.1 (see Appendix B). Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented.
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  7. Life expectancy of ≥ 12 weeks
  8. Willing and able to comply with scheduled visits and study procedures
  9. Adequate organ, bone marrow and coagulation function as shown by:

    • Absolute neutrophil count (ANC) ≥ 1.5 ×109/L
    • Platelets ≥ 75 ×109/L
    • Hemoglobin (Hgb) ≥ 5.6 mmol/L
    • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN (or ≤ 5 if hepatic metastases are present)
    • Total serum bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients known to have Gilbert Syndrome)
    • Creatinine clearance ≥60 ml/min
  10. Written informed consent obtained before any screening procedure and according to local guidelines.
  11. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade ≤1, except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion.

Exclusion Criteria:

  1. HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive) and ER-negative patients are not eligible
  2. No more than two lines of chemotherapy for advanced disease
  3. Resolution of side-effects from previous chemotherapy > grade 1 (except for alopecia)
  4. Radiotherapy within four weeks prior to enrollment is not allowed except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment.
  5. 30% or more marrow-bearing bone being irradiated. Other primary tumors within the last 5 years before study entry are not allowed, except for adequately controlled basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
  6. Previous or current CNS metastases, carcinomatous meningitis, are not allowed. A CT or MRI of the brain must be performed within 4 weeks prior to registration if the presence of metastases at this site is suspected.
  7. Evidence of clinically significant cardiovascular or pulmonary disease or any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect patient compliance with study routines, or places the patient at high risk from treatment related complications. (e.g lactose intolerance)
  8. Previously received trifluridine/tipiracil
  9. Since trifluridine/tipiracil contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine
  10. Diagnosis of any other malignancy prior to registration, except those that are not believed to influence the patient's prognosis and do not require any further treatment.
  11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: M.M.E.M. Bos, MD PhD +31-107034897 m.bos@erasmusmc.nl
Contact: R.M. Bijlsma, MD PhD +31 88 75 555 55 R.M.Bijlsma@umcutrecht.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04489173
Other Study ID Numbers  ICMJE BOOG 2019-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Borstkanker Onderzoek Groep
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Borstkanker Onderzoek Groep
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Erasmus Medical Center
  • UMC Utrecht
  • Servier
  • BOOG Study Center
Investigators  ICMJE
Study Director: A. Elise van Leeuwen-Stok, PhD BOOG Study Center
PRS Account Borstkanker Onderzoek Groep
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP