Breast Cancer Clinical Trial
Official title:
A Cancer Research UK Phase I/II Open Label Study to Evaluate the Safety, Endocrine Effects and Anti-tumour Activity of Abiraterone Acetate (CB7630) in Patients With Oestrogen (ER) or Androgen Receptor (AR) Positive Advanced or Metastatic Breast Carcinoma
RATIONALE: Abiraterone acetate may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of abiraterone
acetate and to see how well it works in treating postmenopausal women with advanced or
metastatic breast cancer.
OBJECTIVES:
Primary
- To evaluate the safety and tolerability of abiraterone acetate in postmenopausal women
with estrogen receptor- or androgen receptor-positive advanced or metastatic breast
cancer. (Phase I)
- To determine the recommended phase II dose of this drug in these patients. (Phase I)
- To evaluate the clinical benefit rate of this drug at 24 weeks in these patients.
(Phase II)
Secondary
- To study the pharmacokinetics of this drug in these patients. (Phase I)
- To determine the endocrine impact of this drug on the pituitary-adrenal-gonad endocrine
axis. (Phase I)
- To estimate the duration of objective tumor response in these patients. (Phase II)
- To correlate response rates and duration of response with the endocrine profile in
these patients. (Phase II)
- To determine overall survival of these patients. (Phase II)
Tertiary
- To enumerate and molecularly characterize circulating tumor cells.
- To identify normal genetic variations that predict resistance to this drug using
pharmacogenomic analysis.
OUTLINE: This is a multicenter, phase I study followed by a phase II study. Patients
enrolled in the phase II portion of the study are stratified according to hormone receptor
status (estrogen receptor [ER]-positive and any androgen receptor [AR] status vs AR-positive
and ER-negative).
Patients receive oral abiraterone acetate once daily on days 1-28. Treatment repeats every
28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically and analyzed for pharmacokinetic assays (phase I
only), pharmacodynamic assays, circulating tumor cells, and pharmacogenomic analysis.
After completion of study treatment, patients are followed for 28 days.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |