A Phase 2 interventional study of Vinorelbine and Capecitabine in Breast Cancer, sponsored by Spanish Breast Cancer Research Group. Terminated at 1 site in Spain. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-26.
Sponsored by Spanish Breast Cancer Research Group · Phase 2, Interventional, and Treatment
Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks.Human epidermal growth factor receptor 2 (HER2) status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization (FISH).
Principal outcome is clinical benefit (complete + partial responses + stable disease). Sample size in each arm has been estimated with the Fleming method. Previous data show a clinical benefit rate of vinorelbine plus capecitabine around 50%. The researchers assume trastuzumab can increase it by 20%. With an alpha error of 0.05 and 80% power, 37 patients per arm are needed.
This is a randomised phase II trial. With a minimum expected benefit rate of 50%, at least 36 patients are needed to choose, with a 90% of probability to be right, the best treatment arm, providing it increases benefit rate at least by 15%.
Assuming a drop-out rate of 10%, the total number of patients needed is 82, 41 per treatment arm.
Patients will be stratified as per investigational site, and presence of visceral metastatic lesion (liver, lung, pleura, heart, peritoneum, suprarenal glands). All patients must receive 2 cycles. If no disease progression is detected, treatment must continue until progression or unbearable toxicity.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 14 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
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Hematology:
Hepatic function:
Renal function:
Exclusion Criteria:
Vinorelbine and capecitabine (VX): vinorelbine 25 mg/m2 iv, days 1 and 8 each cycle (21 days), followed of capecitabine 825 mg/m2, orally, twice a day, days 1-14 each cycle (21 days).
Drug: Vinorelbine · Drug: Capecitabine
Vinorelbine, capecitabine and trastuzumab (VXH): vinorelbine 25 mg/m2 iv, days 1 and 8 each cycle (21 days), followed of capecitabine 825 mg/m2, orally, twice a day, days 1-14 each cycle (21 days) and trastuzumab 4 mg/kg iv (loading dose first week), followed by 2 mg/kg weekly.
Drug: Vinorelbine · Drug: Capecitabine · Drug: Trastuzumab
Also known as: Navelbine
Also known as: Xeloda
Also known as: Herceptin
Clinical benefit rate
Clinical benefit rate is defined as the rate of objective responses (complete responses and partial responses to treatment) and stabilizations, with a minimum duration of 24 weeks.
Time frame: Through study completion, an average of 1 year
Time to progression (TTP)
Tumor assessments will be performed until disease progression in order to evaluate the TTP. TTP is defined as the time from the date of the first dose to the first date of objectively determined progressive disease. For patients not known to have objectively-determined progressive disease, TTP will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression, TTP will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation systemic anticancer therapy.
Time frame: Through study completion, an average of 1 year
Objective Response Rate (ORR)
Tumor response will be assessed using RECIST criteria. The best response across all treatment will be recorded. ORR is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline.
Time frame: Through study completion, an average of 1 year
Response Duration (RD)
RD is defined as the time from the date when the measurement criteria are met for complete response (CR) or partial response (PR) (whichever status is recorded first) until the date of first observation of disease progression or death occurred. For responding patients not known to have died as of the data cut-off date and who do not have progression, duration of response will be censored at the date of last visit with adequate assessment. For responding patients who receive subsequent anticancer therapy (after discontinuation from the study treatment) prior to progression, duration of response will be censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy.
Time frame: Through study completion, an average of 1 year
The Number of Participants Who Experienced Adverse Events (AE)
All AE suffered by patients will be recorded and graduated by the NCI CTCAE v1.0.
Time frame: Through study completion, an average of 1 year
Overall Survival (OS)
OS was defined as the time elapsed from first treatment until death from any cause.
Time frame: Through study completion, an average of 1 year
Ran from Nov 2005 to primary completion in Jun 2009, 43 months.
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This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trastuzumab
Spanish Breast Cancer Research Group