N/A
Completed N=143
Evaluation of Hypertension as a Predictor of Efficacy Bevacizumab in Metastatic Breast Cancer and Colorectal Cancer
Source: ClinicalTrials.gov NCT01733628 ↗Enrolled (actual)
143
Serious AEs
16.3%
Results posted
Dec 2019
Primary outcomePrimary: Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) — 19; 11; 6; 4 Participants — p=0.8166
Summary
This is a multicenter, post-authorization observational with prospective follow-up (EPA-SP) study. Will be involved 137 metastatic breast cancer patients or metastatic colorectal cancer. The hypertension will be evaluated as a predictor of efficacy of bevacizumab associated with chemotherapy, in terms of progression-free survival (PFS) (Main endpoint).
The duration of the study will be approximately 42 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) |
19; 11; 6; 4; 1; 1 | 0.8166 |
| PRIMARY Progression Free Survival (PFS) |
10.19 | — |
| SECONDARY Number of Participants With "White Coat" AHT While at Home |
60; 6; 47; 73; 10; 30 | — |
| SECONDARY Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure |
94; 14; 5; 66; 5; 42 | — |
Eligibility Criteria
Inclusion Criteria
May only participate in the study patients (women and men) who meet all the following criteria:
- MCC or MBC patients with chemotherapy and bevacizumab established indication. The first line systemic treatment planned for patients with MCC should be based in combination chemotherapy (oxaliplatin / irinotecan plus fluoropyrimidine) associated with bevacizumab. The first line systemic treatment planned for MBC patients should be based on a combination of paclitaxel or capecitabine plus bevacizumab.
- Presence of measurable or evaluable disease according to RECIST 1.1, for the evaluation of the response to treatment.
- Equal or more than 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Signed written informed consent.
- Women of childbearing potential must have a negative pregnancy test in serum or urine conducted in the 7 days prior to the administration of chemotherapeutic treatment assigned by your doctor, and accept the use of double barrier contraception during the study (Note : Patients who are not of childbearing age may participate without using contraceptives. Women who are of childbearing age are those who: 1) have reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) within postmenopausal interval as determined by the laboratory, or 12 months of spontaneous amenorrhea), 2) have undergone bilateral oophorectomy with or without hysterectomy 6 weeks before, or 3) have undergone bilateral tubal ligation). Men also should use an adequate contraception method.
Exclusion Criteria
Patients meeting any of the following circumstances will be excluded from the study:
- Have received prior systemic anticancer therapy with chemotherapy for advanced disease or prior treatment with bevacizumab.
- Treatment with an investigational agent or biological agent within 30 days prior to inclusion in the study.
- Contraindications to treatment with chemotherapy and bevacizumab according to summary products characteristics.
- Background or current history (within five years before the start of treatment) of other malignancies, except for colorectal carcinoma and breast cancer (patients with basal cell carcinoma or squamous cell skin or cervical carcinoma in situ treated curative may be included in the study).
- Life expectancy less than 3 months.
- Patients who are pregnant or breastfeeding.
- Patients with an inadequate organ function (bone marrow, kidney and liver)
Data sourced from ClinicalTrials.gov (NCT01733628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.