deltatrials
Unknown PHASE2 INTERVENTIONAL NCT00003066

Docetaxel Combined With Estramustine in Treating Women With Metastatic Breast Cancer

Phase II Evaluation of Docetaxel Combined With Estramustine Phosphate in Patients With Metastatic Breast Cancer

Sponsor: Herbert Irving Comprehensive Cancer Center

Conditions Breast Cancer
Updated 6 times since 2017 Last updated: Jan 3, 2014 Started: Feb 28, 1997
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Breast Cancer and is currently ongoing. Herbert Irving Comprehensive Cancer Center leads this study, which shows 6 recorded versions since 1997 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

OBJECTIVES: I. Determine the response rate, duration of response, duration of survival, and quality of life effects of docetaxel and estramustine combination in women with metastatic breast cancer. OUTLINE: Patients receive estramustine 3 times a day for 3 days. Docetaxel begins on day 3 after the a.m. dose of estramustine and is given as a 1 hour infusion intravenously. Courses repeat every 21 days. If disease responds or is stable, treatment continues at the highest tolerance percentage of prescribed dose until appearance of disease progression. If complete response is documented, an additional 2 courses are given. Patients should receive a minimum of 2 courses unless rapid progression or unacceptable toxicity occur. Patients are followed monthly. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

OBJECTIVES: I. Determine the response rate, duration of response, duration of survival, and quality of life effects of docetaxel and estramustine combination in women with metastatic breast cancer.

OUTLINE: Patients receive estramustine 3 times a day for 3 days. Docetaxel begins on day 3 after the a.m. dose of estramustine and is given as a 1 hour infusion intravenously. Courses repeat every 21 days. If disease responds or is stable, treatment continues at the highest tolerance percentage of prescribed dose until appearance of disease progression. If complete response is documented, an additional 2 courses are given. Patients should receive a minimum of 2 courses unless rapid progression or unacceptable toxicity occur. Patients are followed monthly.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE2

  2. Sep 2024 — Present [monthly]

    Unknown PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE2

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE2

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Unknown Status PHASE2

    First recorded

Feb 1997

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Herbert Irving Comprehensive Cancer Center
Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations