TrialA Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
Trial details
- Registry ID
- NCT02540330
- Phase
- Phase 2
ATOS
Atossa Therapeutics, Inc.
Company identity checked against sources
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3Trials in this database
7Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far
Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.
Completion dates · Pro
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Included trials
Check company identity source| Trial | Sponsor | Phase | Status | Primary completion |
|---|---|---|---|---|
| A Pre-Surgical PK Study of IM and Intraductally Delivered FulvestrantNCT02540330 | ATOS | Phase 2 | Terminated | 2020-08-13Actual |
| Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast DensityNCT05068388 | ATOS | Phase 2 | Completed | 2024-06-14Actual |
| (Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast CancerNCT05607004 | ATOS | Phase 2 | Active not recruiting | 2026-11Estimated |
Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density
Trial details
- Registry ID
- NCT05068388
- Phase
- Phase 2
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
Trial details
- Registry ID
- NCT05607004
- Phase
- Phase 2
Latest recorded trial changes
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
NCT05607004 · Atossa Therapeutics, Inc.
Recruitment status
Recorded edit− Previous value
Recruiting
+ Updated value
Active not recruiting
Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density
NCT05068388 · Atossa Therapeutics, Inc.
Completion date type
Recorded edit− Previous value
Estimated
+ Updated value
Actual
Primary completion date
Recorded edit− Previous value
2024-08-28
+ Updated value
2024-06-14
Recruitment status
Recorded edit− Previous value
Active not recruiting
+ Updated value
Completed
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
NCT05607004 · Atossa Therapeutics, Inc.
Primary outcomes · main study measures
Text edit · unverified significance− Previous value
measure: PK Cohort - (Z)-endoxifen steady-state plasma concentrations; measure: Treatment Cohort Part 2a - Endocrine sensitive disease rate based on Ki-67 percent after 4 weeks of treatment; measure: Treatment Cohort Part 2b - Endocrine sensitive disease rate based on Ki-67 percentage after 24 weeks of treatment.
+ Updated value
measure: PK Cohort - (Z)-endoxifen steady-state plasma concentrations; measure: For Analysis of Cohort A (Treatment Cohort): determine whether the week 4 Ki-67≤10% rate is at least 65%; measure: For analysis Cohort B (Treatment Cohort): determine the objective tumor response rate at 24 weeks
The saved outcome text may be shortened. Check the source for full wording.
Enrollment · participant count
Recorded edit− Previous value
count: 214; type: ESTIMATED
+ Updated value
count: 87; type: ESTIMATED
Primary completion date
Recorded edit− Previous value
2026-02
+ Updated value
2026-11