A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer
Sponsor: Ortho Biotech Products, L.P.
Terminated
Study stopped to avoid treating enrolled subjects to hemoglobin levels higher than those specified in current labeling.
This PHASE3 trial investigates Anemia and Breast Neoplasms and is currently terminated or withdrawn. Ortho Biotech Products, L.P. leads this study, which shows 9 recorded versions since 2002 — 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)Studies of the effect of erythropoietin on rat and mouse brain suggests a neuroprotective and cognitive-enhancing effect of this hormone. The objective of this study was to quantify and compare the incidence of chemotherapy-related impairment of cognitive and executive function in breast cancer patients randomized to receive PROCRIT versus placebo while receiving adjuvant anthracycline-based chemotherapy with or without a Taxane and to evaluate the effect of PROCRIT® on the incidence of asthenia (severe fatigue), quality of life (QoL), and mood. Patients received study medication injections (40,000 units) under their skin once every week for 12 to 24 weeks of chemotherapy. Doses were adjusted depending on the patients' hemoglobin level up to a maximum of 60,000 units.
Studies of the effect of erythropoietin on rat and mouse brain suggests a neuroprotective and cognitive-enhancing effect of this hormone. The objective of this study was to quantify and compare the incidence of chemotherapy-related impairment of cognitive and executive function in breast cancer patients randomized to receive PROCRIT versus placebo while receiving adjuvant anthracycline-based chemotherapy with or without a Taxane and to evaluate the effect of PROCRIT® on the incidence of asthenia (severe fatigue), quality of life (QoL), and mood. Patients received study medication injections (40,000 units) under their skin once every week for 12 to 24 weeks of chemotherapy. Doses were adjusted depending on the patients' hemoglobin level up to a maximum of 60,000 units.
Status Flow
Change History
9 versions recorded-
Sep 2024 — Present [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
-
Dec 2021 — Jul 2024 [monthly]
Terminated PHASE3
-
Jan 2021 — Dec 2021 [monthly]
Terminated PHASE3
-
Nov 2020 — Jan 2021 [monthly]
Terminated PHASE3
▶ Show 4 earlier versions
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Jun 2018 — Nov 2020 [monthly]
Terminated PHASE3
-
May 2018 — Jun 2018 [monthly]
Terminated PHASE3
-
Aug 2017 — May 2018 [monthly]
Terminated PHASE3
-
Jan 2017 — Aug 2017 [monthly]
Terminated PHASE3
First recorded
Dec 2002
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Ortho Biotech Products, L.P.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.