Metastatic Breast Cancer Clinical Trial
Official title:
The Study of Avastin (Bevacizumab) to Reverse Acquired Estrogen Independence in Metastatic Breast Cancer Patients Previously Responsive to Hormonal Therapy: A Phase II Trial
The purpose of this study is to determine if acquired hormone therapy resistance can be reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate toxicity of the combination of hormone treatment plus Avastin (Bevacizumab).
This is a single institution, open-label study designed to evaluate safety and efficacy of
Avastin (Bevacizumab) combined with an endocrine agent in patients with estrogen and/or
progesterone receptor positive metastatic breast carcinoma who have acquired resistance to at
least one hormonal agent. Patients will be treated with the same hormonal agent that was used
previously assuming that the patient had a partial or complete response (for at least 6
months) followed by a clear disease progression using the Response Evaluation Criteria in
solid Tumors (RECIST Criteria). Patients with stable disease for a prolonged time (for at
least 6 months) will be also eligible to enter in the trial. Patients who have not had
interval studies to evaluate disease response will be considered eligible if they have
remained clinically stable (i.e. stable performance status (PS), no increasing pain) and on
the same hormone for at least 6 months, and now they have signs and symptoms of clinical
progression (i.e. elevated tumor markers, increasing bone pain, worsening performance
status). Patients must have histologically confirmed measurable and/or evaluable metastatic
breast cancer with positive estrogen and/or progesterone receptors. Patients can have up to
an 8-12 week break in therapy (discontinuation of hormonal therapy) and still remain eligible
for the study as long as the documentation of disease progression is determined before the
8-12 week break in hormonal therapy.
The type and dose of the hormonal agent that will be used in this trial will be the same one
that the patient used before progression. Hormonal therapy may include any estrogen
deprivation reagent such as Tamoxifen, Anastrazole, Exemestane, Letrozole, or Fulvestrant.
All patients will receive Avastin (Bevacizumab) 15 mg/kg IV every three weeks. Based on
statistical evaluations, 30 patients will be enrolled. The first evaluation of efficacy will
be done at week 6; patients with objective response or stable disease will continue therapy
with re-staging every 6 weeks until evidence of disease progression. Patients with
progression of disease will be taken off study (see appendix A). PET scan will be done at
baseline and only in the first evaluation (6 weeks) to obtain early "metabolic response data"
that will be correlated with objective response and time to disease progression (PET data on
week 6 will not be used to evaluate response and to make therapeutic decisions). PET
"metabolic response" will be defined as a >20% reduction in Standardized Uptake Value (SUV).
Safety will be assessed by the recording of adverse events, serious adverse events,
laboratory test results, and changes in vital signs. A positive response to Avastin
(Bevacizumab) (reversal of hormonal resistance) will be defined as an objective response or
stable disease of ≥ 3 months duration. All concomitant medication must be documented.
Additionally, any diagnostic, therapeutic or surgical procedure performed during the study
period, should be recorded including the date, indication, description of the procedure(s)
and any clinical findings.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04872608 -
A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer
|
Phase 1 | |
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 | |
Completed |
NCT02506556 -
Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05534438 -
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
|
Phase 2 | |
Recruiting |
NCT03368729 -
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT04103853 -
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
|
Phase 1 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Active, not recruiting |
NCT03147287 -
Palbociclib After CDK and Endocrine Therapy (PACE)
|
Phase 2 | |
Not yet recruiting |
NCT06062498 -
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05383196 -
Onvansertib + Paclitaxel In TNBC
|
Phase 1/Phase 2 | |
Recruiting |
NCT04095390 -
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04432454 -
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
|
Phase 2 | |
Recruiting |
NCT03323346 -
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05744375 -
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
|
Phase 2 | |
Completed |
NCT02924883 -
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
|
Phase 2 | |
Completed |
NCT01881230 -
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
|
Phase 2/Phase 3 | |
Completed |
NCT01942135 -
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
|
Phase 3 | |
Active, not recruiting |
NCT04448886 -
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
|
Phase 2 | |
Completed |
NCT01401959 -
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
|
Phase 2 | |
Terminated |
NCT04720664 -
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
|
Phase 2 |