Phase II Treatment of Metastatic Breast Cancer With Fulvestrant or Tamoxifen
|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: NCT02913430|
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Fulvestrant Drug: Tamoxifen||Phase 2|
The primary objectives are to compare progression-free survival (PFS) in fulvestrant and tamoxifen arms in patients unselected by ESR1 mutation, and in the subset of patients with ESR1-mt tumors assessed primarily from ctDNA at enrollment.
Patients with ER+ breast cancer who had 1 to 3 prior lines of endocrine therapy and up to one line of chemotherapy for MBC, excluding fulvestrant and tamoxifen, will be randomized in a 1:1 ratio to receive fulvestrant 500mg IM Q28 days with one extra dose on D15 of the first cycle (as a loading dose) or tamoxifen 20mg PO daily.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Metastatic Breast Cancer With Fulvestrant or Tamoxifen: A Randomized Phase II Trial With ESR1 Mutation Tested in Circulating Tumor DNA.|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2019|
Active Comparator: Arm A
fulvestrant administered 500mg IM Q28 days
500mg IM Q28 days
Active Comparator: Arm B
Tamoxifen is administered orally, at a dose of20mg PO Qdaily
20mg PO Qdaily
- Co-primary objectives to compare progression-free survival (PFS) in fulvestrant and tamoxifen arms in patients unselected by ESR1 mutation, and in the subset of patients with ESR1-mt tumors assessed primarily from ctDNA at enrollment. [ Time Frame: 6 months after last subject is enrolled ]PFS is defined as the duration of time from time of randomization to time of progression or death, whichever occurs first. PFS for a subject without an event will be censored on the date of last tumor assessment. If an interval of 6 months passes without a tumor assessment, PFS will be censored at the time of the earlier tumor assessment, even if an event (progressive disease or death) is later observed.
- Response rate compared between the tamoxifen and fulvestrant arms in the entire cohort and in the ESR1-mt [ Time Frame: 6 months after last patient enrolled ]
- Overall Survival compared between the tamoxifen and fulvestrant arms in the entire cohort and in the ESR1-mt [ Time Frame: 5 years after study entry, or until all patients deceased ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v. 4.0 in each treatment arm [ Time Frame: while on study treatment, estimate 6 months from study entry in all patients ]Treatment related adverse events will be assessed in all patients as assessed by CTCAE v4.0. This will be determined at the monthly visits.
- Clinical benefit rate (defined as CR+PR+ stable disease at any tumor assessment) and clinical benefit rate at 6 months (CBR6) (defined as CR+PR+ stable disease for at least 6 months) [ Time Frame: 6 months after last subject is enrolled ]
- Assessment of concordance of ESR1 status in plasma and biopsy samples [ Time Frame: 6 months after last subject is enrolled ]
- Assessment of longitudinal changes in circulating levels of ESR1-mt and correlation with response [ Time Frame: 6 months after last subject is enrolled ]
- Assessment of concordance with metastatic biopsies and archived primary tumor samples, determination of ESR1 status at diagnosis in archived tumor samples. [ Time Frame: 6 months after last subject is enrolled ]
- Assessment of the functionality of ESR1 in tumor biopsies collected prior to and following treatment with fulvestrant as assessed by RNAseq [ Time Frame: 12 months after last subject is enrolled ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913430
|Contact: Shannon L. Cieplyemail@example.com|
|United States, Pennsylvania|
|Magee-Womens Hospital UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Shannon L. Cieply 412-641-2357|