BRMS1Phase 2GLICO-0801NCT01050322
Safety Study in Subjects With Metastatic Breast Cancer Who Progressed After Taxanes Treatment.
A Phase 2 study testing Lapatinib Vinorelbine, Lapatinib Capecitabine and Gemcitabine Lapatinib in people with BRMS1 and Performance Status Zero to Two for Beginning the Study, run by Latin American Cooperative Oncology Group at 18 sites in 3 countries.
Trial summary
Despite these initial positive signals in recent statistics, breast cancer continues to claim a substantial number of lives approximately 500,000 deaths worldwide in 2005 Thus the current treatment paradigm - surgery, radiation and systemic chemo and or hormonal therapy and biological therapies -still fails to cure a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BRMS1, Performance Status Zero to Two for Beginning the Study, Patient With a Maximum of One Chemotherapy
- What is being tested?
- Lapatinib Vinorelbine, Lapatinib Capecitabine and Gemcitabine Lapatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Nov 2009to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained according to local ethical committee requirements.
- Subjects must be older than 18 years old.
- Histologically confirmed invasive adenocarcinoma of the breast which is stage IIIb, stage IIIc with T4 lesion, or stage IV disease [according to AJCC 6th edition]
- Documented progression after taxane based treatment for ErbB2 positive patients for 1st line metastatic breast cancer or documented progression after taxane based regimens as adjuvant or neo-adjuvant therapy. Patients may have had a maximum of one prior treatment with a chemotherapy regimen for metastatic disease.
- Patients must have at least 1 measurable lesion defined by RECIST as follows:
- X-ray, physical exam > 20 mm.
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- Conventional CT scan > 20 mm.
- Spiral CT scan > 10 mm.
- Measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease.
- Local laboratory confirmed HER2/neu over expressing and/or amplified disease in the invasive component of the primary or metastatic lesion as defined by at least one of the following based local results:
- 3+ overexpression by IHC (> 30% of invasive tumour cells).
- 2+ or 3+ (in 30% or < % of neoplastic cells) over expression by IHC AND in situ hybridization (FISH/CISH) test demonstrating HER2 gene amplification.
- HER2 gene amplification by FISH or CISH. (> 6 HER2 gene copies per nucleus, or a FISH ratio (HER2 gene copies to chromosome 17 signals) of > than 2.2.
- Prior therapy must have included a taxane regimen. Patients must have received either:
- Prior adjuvant treatments with taxanes-containing chemotherapy regimens providing that at least 6 months has elapsed from the last dose of adjuvant or neoadjuvant chemotherapy and all treatment related adverse events are < grade 1 at the time of randomization; OR
- Prior treatment with taxane based chemotherapeutic regimens for first line metastatic breast cancer or prior taxane based neoadjuvant regimens for locally advanced disease providing that at least 4 weeks has elapsed since the last dose of therapy for metastatic disease and all treatment related adverse events are < grade 1 at the time of randomization.
- In regions where trastuzumab is available with no barriers to access, patients must have also received prior trastuzumab alone or in combination with chemotherapy in order to be eligible as follows:
- Prior treatment with Trastuzumab includes only first line metastatic setting; OR
- Prior trastuzumab treatment in neoadjuvant / adjuvant setting provided that at least 6 months has elapsed from last dose of adjuvant / neoadjuvant Trastuzumab , and all treatment related adverse events are < grade 1 at the time of randomization.
- Prior treatment with anthracyclines in the adjuvant or first line metastatic setting are permitted provided that therapy has been discontinued before randomization, and all treatment related adverse events are < grade 1 at the time of randomization.
- Prior treatment with endocrine therapy in the adjuvant or metastatic setting are permitted provided that therapy has been discontinued before randomization, and all treatment related adverse events are < grade 1 at the time of randomization.
- Prior treatments with radiation therapy for palliative management of metastatic disease , to a limited area (e.g., palliative treatment for painful disease) other than the sole site of measurable and assessable disease is allowed however, subjects must have completed treatment at least 4 weeks of the last dose of radiotherapy prior to starting study drugs, and must have recovered from all treatment-related toxicities prior to Day 1.
- 11. Life expectancy of at least 6 months.
- 12. ECOG PS 0-2.
- 13. Patients must have normal organ and marrow function measured within 14 days prior to randomization as defined below:
- System Laboratory Values
- Hematologic
- Absolute neutrophil count (ANC) > 1.5 X 109/L
- Hemoglobin1 > 9 g/dL
- Platelets > 100 X 109/L
- Hepatic
- Albumin > 2.5 gr /dl
- Total bilirubin > 1.5 X upper limit of normal (ULN)
- AST and ALT > 2.5 X ULN
- Renal
- Serum Creatinine > 1.5 mg/dL o 132.6 micromol/L
- Or, if serum creatinine > 1.5 mg/dL, Calculated creatinine clearance > 50 mL/min
- Patients may not have had a transfusion within 7 days of screening assessment
- 14. CT head/MRI within 4 weeks prior to randomization.
- 15. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to registration.
- 16. Patients must have at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST, Therasse, 2000). Measurable lesions may be in the field of prior adjuvant irradiation. However, there must be at least a 4 week period between the last radiation treatment and the baseline scan documenting disease status. Documented progression of the irradiated lesion is also required for the lesion to be considered measurable.
- 17. Subjects must have a cardiac ejection fraction within the institutional range of normal as measured by ECHO (echocardiogram) or alternatively by MUGA (Multigated Acquisition) scan. Cardiac ejection fraction > 50% and within the institutional range of normal as demonstrated by echocardiogram or alternatively by MUGA scan within 4 weeks of randomization Subjects with known uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure are NOT eligible;
- 18. Subjects must complete all screening assessments as outlined in the protocol.
Who cannot join
- Pregnant or lactating women.
- Prior therapy with other anti Erbb1 or antiErbB2 targeted agent rather than Trastuzumab only limited to 1st line treatment of metastatic disease OR as adjuvant/neoadjuvant therapy.
- Prior exposure to gemcitabine , vinorelbine and capecitabine for 1st line treatment of recurrent-metastatic disease OR as adjuvant / neoadjuvant therapy.
- Treatment in the 14 days prior to randomization with anti-cancer therapy (tumor embolization, chemotherapy , immunotherapy, biological therapy, or hormonal therapy) or treatment with mitomycin within 6 weeks prior to randomization. Such treatment may not be resumed or begun after study entry. Note: Patients receiving bisphosphonate therapy prior to randomization may continue for the duration of study participation, however bisphosphonates should not be initiated following study entry.
- Prophylactic use of bisphosphonates in subjects without bone disease is not permitted, except for the treatment of osteoporosis.
- Active CNS metastases.
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- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, serious non-healing wound/ulcer/bone fracture, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- Have current active hepatic or biliary disease(with exception of patients with Gilbert syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- History of other malignancy. 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.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Concurrent treatment with an investigational agent or participation in another clinical trial.
- Used an investigational drug within 30 days or 3 half-lives, whichever is longer, preceding the first dose of therapy.
- History of immediate or delayed hypersensitivity or idiosyncrasy to drugs chemically parented to Lapatinib or navelbine or capecitabine or gemcitabine and its excipients.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
Brazil9 sites
Dra. Yeni Veronica Neron
Florianópolis, Santa Catarina, 88034-000
Dr. Gustavo Ismael
Jaú, São Paulo, 17210120
Dr. Carlos Barrios
Porto Alegre, Rio Grande do Sul, 90610-000
Dr. José Bines
Rio de Janeiro, Rio de Janeiro, 20560-120
Dr. Carlos Alberto Sampaio
Salvador, Estado de Bahia, 41950-610
Dra. Patricia Xavier Santi
Santo André, São Paulo, 09060-870
Dr. Max Mano
São Paulo, São Paulo, 01246-000
Dr. Marcello Fanelli
São Paulo, São Paulo, 01509-900
Dra. Célia Tosselo de Oliveira
São Paulo, São Paulo, 03102-002
Argentina8 sites
Dr. Guillermo Lerzo
Buenos Aires
Dr. Eduardo Richardet
Córdoba
Dr. Adolfo Capó
Mendoza
Dr. Juan Lacava
Neuquén
Dra. Mirta Varela
Quilmes
Dr. Luis Fein
Rosario
Dr. Jose Zarba
San Miguel de Tucumán
Dr. Cesar Blajman
Santa Fe
About this study
Official title: A Randomized Open-Label, Phase II Study of Lapatinib-capecitabine or Lapatinib-vinorelbine or Lapatinib/Gemcitabine in Subjects With Her2/Neu Amplified Metastatic Breast Cancer Patients Progression After Taxanes Treatment
Despite these initial positive signals in recent statistics, breast cancer continues to claim a substantial number of lives approximately 500,000 deaths worldwide in 2005 Thus the current treatment paradigm - surgery, radiation and systemic chemo and or hormonal therapy and biological therapies -still fails to cure a significant number of women with early breast cancer and new treatment strategies are needed to improve current results both in early and advance disease.
Recurrent or metastatic breast cancer is an incurable malignancy with a median survival of 20-24 months [Hortobagyi , 1998] and this has not changed significantly over the last decade with fewer than 20% of patients still alive at 5 years after a diagnosis of recurrence. Although there have been small improvements in survival with the new therapies, metastatic breast cancer remains an incurable and, ultimately, fatal disease. The introduction of novel combination therapies have the potential to target different pathways in the cancer cell, leading to improved efficacy. Further studies to optimize combination therapy, while ameliorating AEs, are critically important to patients with metastatic breast cancer.
Read more
Lapatinib is an oral tyrosine kinase inhibitor which potently inhibits both EGFR and HER2[Spector, 2005]. Lapatinib in combination with capecitabine is approved in more than 20 countries for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2. All patients in the study leading to the lapatinib approval had received prior therapy including an anthracycline, a taxane, and trastuzumab.
The relevance of the HER2/neu target in breast cancer, combined with the promising preclinical and clinical data regarding the use of lapatinib, provide the rationale for a formal evaluation of this agent combined with other non taxane agents as gemcitabine or vinorelbine after progression on taxanes and trastuzumab based therapies in metastatic disease setting as these chemotherapy options are used in daily practice in this subset of patients.
This is a randomized phase II, open label,multicentric , international, 3 arms treatment study in patients with confirmed HER2+ metastatic breast cancer after taxane progression . The main objective is to investigate the (CBR) and safety in 3 different combinations of Lapatinib therapy (plus capecitabine or gemcitabine or vinorelbine) and to determine whether either, or both, of Lapatinib /Vinorelbine or Lapatinib/Gemcitabine can be considered a reasonable alternative to the established Lapatinib/Capecitabine standard combination . The decision as to whether to study either of the new combinations further will be based on both the toxicity and the efficacy profiles.
Read the detailed description
In areas where trastuzumab is available with no barriers to access, all patients must have received trastuzumab in the adjuvant or metastatic setting . However, in countries where trastuzumab is not approved or is not available to patients due to reimbursement or other considerations, trastuzumab naïve patients are allowed considering the efficacy data of Lapatinib in this subset of patients.
This trial uses a design to ensure a selection of one or more of the better treatment combination for additional clinical Approximately (165), who meet the criteria for efficacy analysis as defined, will be enrolled in the study in a single stage process. The sample size will be accrued in 16 months, with further follow-up for a 24 months study period from randomization or until progression.
The study includes a Screening/Baseline Period, a Treatment Period and a post-treatment Follow-Up Period. Patients will continue to receive investigational products until disease progression or early discontinuation from investigational product for other reasons. Patients who discontinue investigational product(s) without disease progression will continue to be evaluated for efficacy until progression or until receiving the first subsequent anti-cancer therapy. Once progression is documented, all patients will be followed for survival at approximately 3-month intervals until death.
- Conditions
- BRMS1, Performance Status Zero to Two for Beginning the Study, Patient With a Maximum of One Chemotherapy, Patient With Progression After Taxanes
- Being tested
- Lapatinib Vinorelbine, Lapatinib Capecitabine, Gemcitabine Lapatinib
- Keywords
- receptor HER two positive, lapatinib, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapatinib VinorelbineDrug
The starting dose of vinorelbine is 25 mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.
Lapatinib CapecitabineDrug
The starting dose of capecitabine is 2000 mg/m2/day, to be divided and given twice daily orally, 12 hours apart, for 14 days, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.
Gemcitabine LapatinibDrug
The starting dose of gemcitabine is 1000mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine Lapatinib | Active comparator | The starting dose of capecitabine is 2000 mg/m2/day, to be divided and given twice daily orally, 12 hours apart, for 14 days, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day. Receives: Drug: Lapatinib Capecitabine |
| Vinorelbine Lapatinib | Experimental | The starting dose of vinorelbine is 25 mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day. Receives: Drug: Lapatinib Vinorelbine |
| Gemcitabine Lapatinib | Experimental | The starting dose of gemcitabine is 1000mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day. Receives: Drug: Gemcitabine Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate
Measured: 6 months
Secondary outcomes (1)
Evaluate: PFS and OS each treatment arm. Determine ORR and duration of response of each treatment. Incidence AE,SAEs Determine quale and quantic toxicities associated with LAPATINIB when administered with other chemotherapy different capecitabine.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BRMS1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050322
- Sponsor's protocol ID
- GLICO-0801
- Acronym
- GLICO-0801
- Status last verified
- Nov 2010
- First submitted
- 14 Jan 2010
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PubMed 34037241
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-Label, Phase II Study of Lapatinib-capecitabine or Lapatinib-vinorelbine or Lapatinib/Gemcitabine in Subjects With Her2/Neu Amplified Metastatic Breast Cancer Patients Progression After Taxanes Treatment
- ClinicalTrials.gov ID
- NCT01050322
- Acronym / sponsor ID
- GLICO-0801 / GLICO-0801
- Conditions
- BRMS1, Performance Status Zero to Two for Beginning the Study, Patient With a Maximum of One Chemotherapy, Patient With Progression After Taxanes
- Keywords
- receptor HER two positive, lapatinib, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite these initial positive signals in recent statistics, breast cancer continues to claim a substantial number of lives approximately 500,000 deaths worldwide in 2005 Thus the current treatment paradigm - surgery, radiation and systemic chemo and or hormonal therapy and biological therapies -still fails to cure a significant number of women with early breast cancer and new treatment strategies are needed to improve current results both in early and advance disease.
Recurrent or metastatic breast cancer is an incurable malignancy with a median survival of 20-24 months [Hortobagyi , 1998] and this has not changed significantly over the last decade with fewer than 20% of patients still alive at 5 years after a diagnosis of recurrence. Although there have been small improvements in survival with the new therapies, metastatic breast cancer remains an incurable and, ultimately, fatal disease. The introduction of novel combination therapies have the potential to target different pathways in the cancer cell, leading to improved efficacy. Further studies to optimize combination therapy, while ameliorating AEs, are critically important to patients with metastatic breast cancer.
Lapatinib is an oral tyrosine kinase inhibitor which potently inhibits both EGFR and HER2[Spector, 2005]. Lapatinib in combination with capecitabine is approved in more than 20 countries for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2. All patients in the study leading to the lapatinib approval had received prior therapy including an anthracycline, a taxane, and trastuzumab.
The relevance of the HER2/neu target in breast cancer, combined with the promising preclinical and clinical data regarding the use of lapatinib, provide the rationale for a formal evaluation of this agent combined with other non taxane agents as gemcitabine or vinorelbine after progression on taxanes and trastuzumab based therapies in metastatic disease setting as these chemotherapy options are used in daily practice in this subset of patients.
This is a randomized phase II, open label,multicentric , international, 3 arms treatment study in patients with confirmed HER2+ metastatic breast cancer after taxane progression . The main objective is to investigate the (CBR) and safety in 3 different combinations of Lapatinib therapy (plus capecitabine or gemcitabine or vinorelbine) and to determine whether either, or both, of Lapatinib /Vinorelbine or Lapatinib/Gemcitabine can be considered a reasonable alternative to the established Lapatinib/Capecitabine standard combination . The decision as to whether to study either of the new combinations further will be based on both the toxicity and the efficacy profiles.
Detailed description
In areas where trastuzumab is available with no barriers to access, all patients must have received trastuzumab in the adjuvant or metastatic setting . However, in countries where trastuzumab is not approved or is not available to patients due to reimbursement or other considerations, trastuzumab naïve patients are allowed considering the efficacy data of Lapatinib in this subset of patients.
This trial uses a design to ensure a selection of one or more of the better treatment combination for additional clinical Approximately (165), who meet the criteria for efficacy analysis as defined, will be enrolled in the study in a single stage process. The sample size will be accrued in 16 months, with further follow-up for a 24 months study period from randomization or until progression.
The study includes a Screening/Baseline Period, a Treatment Period and a post-treatment Follow-Up Period. Patients will continue to receive investigational products until disease progression or early discontinuation from investigational product for other reasons. Patients who discontinue investigational product(s) without disease progression will continue to be evaluated for efficacy until progression or until receiving the first subsequent anti-cancer therapy. Once progression is documented, all patients will be followed for survival at approximately 3-month intervals until death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Capecitabine Lapatinib | Active comparator | Drug: Lapatinib CapecitabineThe starting dose of capecitabine is 2000 mg/m2/day, to be divided and given twice daily orally, 12 hours apart, for 14 days, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day. |
| Vinorelbine Lapatinib | Experimental | Drug: Lapatinib VinorelbineThe starting dose of vinorelbine is 25 mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day. |
| Gemcitabine Lapatinib | Experimental | Drug: Gemcitabine LapatinibThe starting dose of gemcitabine is 1000mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- Signed informed consent must be obtained according to local ethical committee requirements.
- Subjects must be older than 18 years old.
- Histologically confirmed invasive adenocarcinoma of the breast which is stage IIIb, stage IIIc with T4 lesion, or stage IV disease [according to AJCC 6th edition]
- Documented progression after taxane based treatment for ErbB2 positive patients for 1st line metastatic breast cancer or documented progression after taxane based regimens as adjuvant or neo-adjuvant therapy. Patients may have had a maximum of one prior treatment with a chemotherapy regimen for metastatic disease.
- Patients must have at least 1 measurable lesion defined by RECIST as follows:
Key exclusion criteria (14 listed)
- Pregnant or lactating women.
- Prior therapy with other anti Erbb1 or antiErbB2 targeted agent rather than Trastuzumab only limited to 1st line treatment of metastatic disease OR as adjuvant/neoadjuvant therapy.
- Prior exposure to gemcitabine , vinorelbine and capecitabine for 1st line treatment of recurrent-metastatic disease OR as adjuvant / neoadjuvant therapy.
- Treatment in the 14 days prior to randomization with anti-cancer therapy (tumor embolization, chemotherapy , immunotherapy, biological therapy, or hormonal therapy) or treatment with mitomycin within 6 weeks prior to randomization. Such treatment may not be resumed or begun after study entry. Note: Patients receiving bisphosphonate therapy prior to randomization may continue for the duration of study participation, however bisphosphonates should not be initiated following study entry.
- Prophylactic use of bisphosphonates in subjects without bone disease is not permitted, except for the treatment of osteoporosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lapatinib VinorelbineThe starting dose of vinorelbine is 25 mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day. | Drug | Vinorelbine Lapatinib |
| Lapatinib CapecitabineThe starting dose of capecitabine is 2000 mg/m2/day, to be divided and given twice daily orally, 12 hours apart, for 14 days, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day. | Drug | Capecitabine Lapatinib |
| Gemcitabine LapatinibThe starting dose of gemcitabine is 1000mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day. | Drug | Gemcitabine Lapatinib |
Primary outcome
Clinical benefit rate
Time frame: 6 months
1 secondary outcome
Evaluate: PFS and OS each treatment arm. Determine ORR and duration of response of each treatment. Incidence AE,SAEs Determine quale and quantic toxicities associated with LAPATINIB when administered with other chemotherapy different capecitabine.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Derived from this study: PubMed 34037241Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lapatinib Vinorelbine, Lapatinib Capecitabine and Gemcitabine Lapatinib in people with BRMS1 and Performance Status Zero to Two for Beginning the Study, run by Latin American Cooperative Oncology Group at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 43 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Brazil, Argentina, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01050322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.