Breast Cancer Clinical Trial
Official title:
First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane Versus a Non Taxane Regimen
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die. Currently patients with breast cancer are treated with
one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue
may help doctors predict how well patients with breast cancer will respond to treatment and
help doctors choose the best drug regimen to treat each patient.
PURPOSE: This randomized phase III trial is studying giving different regimens of
chemotherapy and comparing how well they work in treating women with large operable or
locally advanced or inflammatory breast cancer. This study is also looking at whether
analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well
patients will respond to treatment and help doctors choose the best drug to treat each
patient.
OBJECTIVES:
Primary
- Compare neoadjuvant fluorouracil, epirubicin, and cyclophosphamide vs docetaxel and
epirubicin followed by radiotherapy and surgery in women with locally advanced,
inflammatory, or large operable breast cancer.
- Assess overall differences between the two arms.
- Assess interaction between p53 status and outcomes in each arm.
- Compare the progression-free survival of patients treated with these regimens.
Secondary
- Compare the distant metastasis-free survival and survival of patients treated with
these regimens.
- Compare the clinical and pathological responses to these regimens in these patients.
- Compare the toxicity of these regimens in these patients.
Translational
- Determine the p53 status in order to study the treatment effect in each of the p53
subgroups and test the interaction between treatment and p53 status.
- Assess the level of agreement between p53 assessment by IHC method and functional test
in yeast.
- Evaluate the prognostic and predictive value of "high risk" p53 mutations.
- Perform a survival analysis according to gene clusters defined with the use of
microarrays.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage
of disease (large T2-3 vs locally advanced or inflammatory), p53 status (negative vs
positive vs unknown), and participating center. Patients are randomized to 1 of 2
chemotherapy treatment arms.
- Arm I (non-taxane arm): Patients receive 1 of 3 chemotherapy regimens comprising
fluorouracil, epirubicin, and cyclophosphamide (FEC) (according to participating
institution).
- FEC 100: Patients receive fluorouracil IV over 15 minutes, epirubicin IV over 1
hour, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3
weeks for 6 courses in the absence of disease progression or unacceptable
toxicity.
- Canadian FEC: Patients receive oral cyclophosphamide on days 1-14 and epirubicin
IV and fluorouracil IV on days 1 and 8. If oral medications are not tolerated,
patients may switch to cyclophosphamide IV on days 1 and 8. Treatment repeats
every 4 weeks for 6 courses in the absence of disease progression or unacceptable
toxicity.
- Tailored FEC: Patients receive fluorouracil IV over 15 minutes, epirubicin IV over
1 hour, and cyclophosphamide IV over 1-2 hours on day 1. Patients also receive
filgrastim (G-CSF) subcutaneously on days 2-15 or until blood counts recover.
Treatment repeats every 3 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II (taxane arm): Patients receive docetaxel IV over 1 hour on days 1, 22, and 43
followed by epirubicin IV over 15 minutes and docetaxel IV over 1 hour on days 64, 85,
and 106 in the absence of disease progression or unacceptable toxicity.
Following chemotherapy, patients may undergo loco-regional therapy comprising radiotherapy
with or without breast conservation surgery or mastectomy. Patients with estrogen- and/or
progesterone-receptor-positive disease also receive tamoxifen or an aromatase inhibitor for
5 years.
Two tumor samples (incisional or tricut biopsies) are taken before chemotherapy. Samples are
analyzed by IHC, a functional test in yeast, and microarray analysis.
Patients are followed every 3 months for 1 year, every 4 months for 1.5 years, and then
every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,850 patients will be accrued for this study within 5.5
years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |