Evaluation of Hypertension as a Predictor of Efficacy Bevacizumab in Metastatic Breast Cancer and Colorectal Cancer

NCT01733628 | Completed Results

• 2 other identifiers: GEICAM/2011-04GEI-BEV-2011-02
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Metastatic Colorectal Cancer; Metastatic Breast Cancer

Keywords

Hypertension; Bevacizumab Response Predictors; Metastatic Breast Cancer; Metastatic Colon Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS)

  The incidence of hypertension was studied during treatment with bevacizumab combined with chemotherapy. A Cox regression analysis was performed, entering as a dependent variable the PFS and as independent variable the Arterial Hypertension (AHT) (yes/no). AHT is introduced in the model of Cox as a time-dependent variable since its situation can change as length of the study. The date on which the AHT changes (passes from normotensive to hypertensive).

  Up to 3 years

• Progression Free Survival (PFS)

  The PFS is the time from the patient receiving the first dose of chemotherapy for advanced disease to the date of progression, the administration of a new antineoplastic treatment that does not contain bevacizumab or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  Up to 3 years

Secondary Outcomes (2)

• Number of Participants With "White Coat" AHT While at Home

  Cycle 1, cycle 2, and cycle 3, up to 9 weeks

• Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure

  Baseline, cycle 1, cycle 2, and cycle 3, up to 9 weeks

Study Arms (1)

Bevacizumab + Chemotherapy

Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic (disseminated at the time of diagnosis) breast cancer or colorectal cancer, treated with bevacizumab.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Roche Farma, S.A: collaborator

Study Sites (10)

Hospital General Universitario de Elche

Elche, Alicante, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital General Universitario de Alicante

Alicante, Spain

Location

Complejo Hospitalario Universitario Reina Sofía

Córdoba, Spain

Location

Complejo Hospitalario de Jaén

Jaén, Spain

Location

Centro Oncológico MD Anderson

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Related Publications (1)

• Rodriguez-Lescure A, Gallego J, Garcia-Alfonso P, Massuti B, Marquez R, Calvo L, Sanchez-Rovira P, Anton A, Chacon JI, Ciruelos E, Ponce JJ, Santaballa A, Valladares-Ayerbes M, Duenas MR, Alonso V, Aparicio J, Encinas S, Robles L, Escudero MJ, Caballero R, Bezares S, Garcia-Ortiz MV, Morales-Ruiz T, de la Haba-Rodriguez J. Hypertension as predictive factor for bevacizumab-containing first-line therapy in metastatic breast and colorectal cancer in BRECOL (GEICAM/2011-04) study. Clin Transl Oncol. 2024 Aug;26(8):1896-1907. doi: 10.1007/s12094-024-03411-w. Epub 2024 Apr 5.

  PMID: 38578537 DERIVED

Related Links

• Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (serum or plasma) Tissue samples

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms; Hypertension; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Scientific Director / Medical Lead / Project Manager
• Organization: Spanish Breast Cancer Research Group

geicam@geicam.org

+34916592870

Study Officials

• Study Director

  Hospital General Universitario de Elche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 27, 2012
• Study Start: October 23, 2012
• Primary Completion: December 19, 2017
• Study Completion: December 19, 2017
• Last Updated: December 4, 2019
• Results First Posted: December 4, 2019

Record last verified: 2019-12

Locations

ES (10)