VEG20007 : Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer
- Conditions
- -C509 Breast, unspecifiedBreast, unspecifiedC509
- Registration Number
- PER-021-06
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 18
1. Women ≥ 21 years of age with a life expectancy ≥ 12 weeks.
2. Degree of performance (PS) according to the Eastern Cooperative Oncology Group (ECOG) of 0 or 1.
3. Invasively confirmed invasive breast cancer of stage IIIb, IIIc with T4 lesion or stage IV disease in initial diagnosis or relapse after surgery of healing intentions.
4. No chemotherapy, immunotherapy, biological therapy or anti-ErbB1 / ErbB2 therapy prior to metastatic or recurrent disease. Prior hormone therapy is allowed for advanced or metastatic disease provided that it has been at least 4 weeks since it has ended.
5. Neoadjuvant therapy and / or previous adjuvant therapy is allowed.
6. Radiation therapy prior to randomization therapy is permitted in a limited area outside the single site of measurable and evaluable disease. However, the subjects must have completed the treatment at least 2 weeks before starting to take the study drugs and must have recovered from all the toxicities related to the treatment.
7. Documented amplification of ErbB2 by FISH in either primary or metastatic tissue.
8. Ability to swallow and retain oral medication.
9. The disease must be measurable in accordance with the Solid Tumor Response Evaluation Criteria (RECIST).
10. Subjects should have chosen treatment with lapatinib and / or pazopanib as initial treatment over other initial treatments for locally advanced or metastatic disease.
11. Suitable organic functions.
12. Fraction of cardiac ejection within the normal range of the institution as measured by echocardiogram.
13. A woman is eligible to enter and participate in this study if: a) She is not able to have children. b) Being able to have children, has a negative pregnancy test at the time of screening and on day 1, and agrees to use adequate contraceptives.
14. Subjects must complete all screening evaluations as described in the protocol.
15. Subjects must provide a written informed consent prior to performing any specific procedure of the study and must agree to the treatment and follow-up.
1. Subjects with bilateral breast cancer, bone metastases as the only site of disease or metastasis of more than 30% of the hepatic parenchyma.
2. History of another neoplastic disease. Subjects who have been disease free for 5 years or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
3. Histology of sarcoma.
4. Concurrent illness or any condition that would make the subject unsuitable for participation in the study.
5. History or clinical evidence of central nervous system (CNS) metastasis or leptomeningeal carcinomatosis, except in the case of individuals with previously treated CNS metastases who are asymptomatic and who have not required steroids or anticonvulsant medication for 2 months or more prior to be enrolled in the study.
6. History of Human Immunodeficiency Virus (HIV) or chronic hepatitis B or C.
7. Malabsorption syndrome, a disease that significantly affects gastrointestinal functioning or gastric or small bowel resection.
8. Disease of active peptic ulcer, inflammatory bowel disease or other gastrointestinal condition that increases the risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess in the 4 weeks prior to starting therapy.
9. Active or uncontrolled infection.
10. Concurrent therapy against cancer.
11. Concurrent treatment with an agent under investigation or participation in another clinical trial.
12. Use of a drug in cancer research within the last 30 days or 5 half-lives, whichever is longer.
13. Previous use of a research or authorized drug directed to either VEGF or VEGF receptors, or ErbB2.
14. Knowledge of immediate or delayed hypersensitivity reactions or idiosyncratic reactions to drugs chemically related to pazopanib or lapatinib.
15. Having taken / received prohibited medication.
16. Prolongation of the corrected QT interval (QTc).
17. History of any of the following cardiac conditions in the last 6 months: a) Angioplasty or cardiac stent. b) Myocardial infarction. c) Unstable angina.
18. History of stroke in the last 6 months.
19. Poorly controlled hypertension.
20. History of deep vein thrombosis (DVT) not treated in the last 6 months.
21. Presence of wounds, fractures or ulcers that do not heal, or the presence of symptomatic peripheral vascular disease.
22. Being on warfarin as a concurrent medication.
23. Evidence of bleeding diathesis or coagulopathy.
24. Major surgical operation, open biopsy or significant traumatic damage in the 4 weeks prior to starting therapy, or anticipation of the need to undergo major surgical intervention during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical evaluation.<br>Imaging: 1) For visible or palpable lesions: CT, MRI. 2) For bone injuries. Bone scan.<br><br>Measure:Survival without disease progression (PFS): Defined as the time from randomization to the earliest date of disease progression or death of the patient from any cause.<br><br>Timepoints:Clinical evaluations: Before starting treatment, Day 1 and every 4 weeks.<br>CT, MRI: Before starting treatment, every 8 weeks and when the study is withdrawn or finished.<br>Bone scan: Before starting treatment, every 6 months and when the study is withdrawn or finished.<br>
- Secondary Outcome Measures
Name Time Method