HER-2 Positive Breast CancerPhase 1CAELYXNCT02131506
A Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer
A Phase 1 study testing Lapatinib, Caelyx in people with HER-2 Positive Breast Cancer and Malignant Neoplasm of Breast, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial summary
A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2 positive pretreated Breast Cancer. Treatment Plan: Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER-2 Positive Breast Cancer, Malignant Neoplasm of Breast
- What is being tested?
- Lapatinib, Caelyx
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2009to Jan 2016
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with histologically or cytologically confirmed diagnosis of breast cancer.
- Locally advanced (Stage IIIb or Stage IIIc with T4 lesion) or metastatic (Stage IV) disease.
- Subjects must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry.
- Subjects must have disease progression (by RECIST) following prior therapy with taxane and trastuzumab-containing regimens (if not contraindicated).
- Patients may have had any number of prior chemotherapy, immunotherapy, hormonal therapy, investigational or radiotherapy regimens, but therapy must be discontinued at least 4 weeks before study entry (6 weeks if the last regimen included BCNU or mitomycin C).
- Age >18 years.
Show all 20Show fewer
- Life expectancy of greater than 12 weeks.
- ECOG performance status <2 (see Appendix A).
- Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram (ECHO).
- Previous anthracycline use inferior of 360 mg/mq for epirubicin and 200 mg/mq for doxorubicin (provided that patients have been off-treatment for at least one year and did not progress under treatment).
- Patients must have normal organ and marrow function as defined below:
- leukocytes >3,000/mL
- absolute neutrophil count >1,500/mL
- platelets >100,000/mL
- total bilirubin < 1.5 X institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal (≤ 5 in patients with liver metastases)
- creatinine < 1.5 X institutional upper limit of normal
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to swallow and retain oral medications.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Prior treatment with Caelyx or Lapatinib.
- Previous malignancy except cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors, or other malignancies curatively treated > 3 years before study entry.
- Patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction, that would confound the evaluation of neurologic and other adverse events. Asymptomatic patients are allowed.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Caelyx and Lapatinib or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment);
- Malabsorption syndrome or any disease significantly affecting gastrointestinal function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer
A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2 positive pretreated Breast Cancer.
Treatment Plan:
Read more
Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq \& Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq \& Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq \& Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq \& Lapatinib 1500 mg die. Three patients will be initially enrolled in each dose level starting from level 1. If none of the first triplet of patients will develop DLT, the dose will be escalated to the next level for the subsequent three patients. If one of the first triplets of patients will develop first-course DLT, a maximum of 3 additional patients will be entered at the same dose level. The MTD is defined as the dose below that at which two patients have experienced DLT. Lapatinib will be self-administered by the patient in an outpatient setting at the dose of the assigned step. Patients will take the drug daily by mouth on days 1 to 21 of each cycle. Caelyx will be administered by intravenous infusion over an exact period of 1 hour (preferably by a pump to guarantee a constant speed of infusion) on day
1 of each cycle repeated every 21 days.
STATISTICAL METHODOLOGY:
Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their first treatment with Caelyx and Lapatinib.
Evaluation of response: all patients included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible.
All conclusions should be based on all eligible patients. Subanalyses may then be performed on the basis of a subset of patients, excluding those for whom major protocol deviations have been identified .However, these subanalyses may not serve as the basis for drawing conclusions concerning treatment efficacy, and the reasons for excluding patients from the analysis should be clearly reported. The 95% confidence intervals should also be provided.
Read the detailed description
Title: A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2 positive pretreated Breast Cancer. Protocol Code: IRST 174.01 Phase: Ib Study Design: open-label,single arm study in patients with advanced HER2 positive breast cancer.
Treatment Plan:
Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq \& Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq \& Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq \& Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq \& Lapatinib 1500 mg die. Three patients will be initially enrolled in each dose level starting from level 1. If none of the first triplet of patients will develop DLT, the dose will be escalated to the next level for the subsequent three patients. If one of the first triplets of patients will develop first-course DLT, a maximum of 3 additional patients will be entered at the same dose level. The MTD is defined as the dose below that at which two patients have experienced DLT. Lapatinib will be self-administered by the patient in an outpatient setting at the dose of the assigned step. Patients will take the drug daily by mouth on days 1 to 21 of each cycle. Caelyx will be administered by intravenous infusion over an exact period of 1 hour (preferably by a pump to guarantee a constant speed of infusion) on day
1 of each cycle repeated every 21 days.
Objectives:
Primary: to define the MTD and the safety profile of Lapatinib (Tyverb) plus Caelyx. Secondary: to preliminarily explore the anti tumour activity, to determine the objective tumor response rate using RECIST criteria.
Sample Size:
No formal sample size estimation is performed as this is primarily a descriptive phase I trial of safety and tolerability.
STATISTICAL METHODOLOGY:
Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their first treatment with Caelyx and Lapatinib. Evaluation of response: all patients included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible. Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data). All of the patients who met the eligibility criteria (with the possible exception of those who received no study medication) should be included in the main analysis of the response rate. Patients in response categories 4-9 should be considered as failing to respond to treatment (PD). Thus, an incorrect treatment schedule or drug administration does not result in exclusion from the analysis of the response rate.
All conclusions should be based on all eligible patients. Subanalyses may then be performed on the basis of a subset of patients, excluding those for whom major protocol deviations have been identified (e.g., early death due to other reasons, early discontinuation of treatment, major protocol violations, etc.). However, these subanalyses may not serve as the basis for drawing conclusions concerning treatment efficacy, and the reasons for excluding patients from the analysis should be clearly reported. The 95% confidence intervals should also be provided.
- Being tested
- Lapatinib, Caelyx
- Keywords
- Advanced HER2 positive Breast Cancer, pretreated breast cancer, advanced disease
- 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, CaelyxDrug
Also called Lapatinib, Caelyx
Lapatinib, Caelix: Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq \& Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq \& Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq \& Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq \& Lapatinib 1500 mg die
| Study group | Role | What they receive |
|---|---|---|
| Lapatinib, Caelyx | Experimental | * Lapatinib is given at escalating doses orally and continuously on days 1-21.
* Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Receives: Drug: Lapatinib, Caelyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD (Maximum Tolerated Dose)
The MTD (Maximum Tolerated Dose) is defined as the dose below that at which two patients have experienced DLT (Dose Limiting Toxicity).
Measured: 6 years
Secondary outcomes (2)
Anti tumour activity of Lapatinib in combination with Caelyx in terms of Objective Response Rate (CR or PR).
Response and progression are evaluated using the RECIST Criteria (Response Evaluation Criteria In Solid Tumors).
Measured: 6 years
Evaluation of toxicity.
All patients will be evaluable for toxicity from the time of their first treatment with Caelyx and Lapatinib, using NCI-CTCAE v.3 (National cancer Institute - Common Terminology Criteria for Adverse Events).
Measured: 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startDec 2009
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Safety reasons
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 HER-2 Positive Breast CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dino Amadori, MD, Principal investigator, IRST IRCCS, Meldola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131506
- Sponsor's protocol ID
- IRST174.01
- Other IDs
- 2009-012996-82, 2009
- Acronym
- CAELYX
- Status last verified
- Feb 2016
- First submitted
- 5 May 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rocca A, Cecconetto L, Passardi A, Melegari E, Andreis D, Monti M, Maltoni R, Sarti S, Pietri E, Schirone A, Fabbri F, Donati C, Nanni O, Fedeli A, Faedi M, Amadori D. Phase Ib dose-finding trial of lapatinib plus pegylated liposomal doxorubicin in advanced HER2-positive breast cancer. Cancer Chemother Pharmacol. 2017 May;79(5):863-871. doi: 10.1007/s00280-017-3279-8. Epub 2017 Mar 24.
PubMed 28341957
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer
- ClinicalTrials.gov ID
- NCT02131506
- Acronym / sponsor ID
- CAELYX / IRST174.01
- Keywords
- Advanced HER2 positive Breast Cancer, pretreated breast cancer, advanced disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety reasons
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 May 2014 (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.
A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2 positive pretreated Breast Cancer.
Treatment Plan:
Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq \& Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq \& Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq \& Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq \& Lapatinib 1500 mg die. Three patients will be initially enrolled in each dose level starting from level 1. If none of the first triplet of patients will develop DLT, the dose will be escalated to the next level for the subsequent three patients. If one of the first triplets of patients will develop first-course DLT, a maximum of 3 additional patients will be entered at the same dose level. The MTD is defined as the dose below that at which two patients have experienced DLT. Lapatinib will be self-administered by the patient in an outpatient setting at the dose of the assigned step. Patients will take the drug daily by mouth on days 1 to 21 of each cycle. Caelyx will be administered by intravenous infusion over an exact period of 1 hour (preferably by a pump to guarantee a constant speed of infusion) on day
1 of each cycle repeated every 21 days.
STATISTICAL METHODOLOGY:
Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their first treatment with Caelyx and Lapatinib.
Evaluation of response: all patients included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible.
All conclusions should be based on all eligible patients. Subanalyses may then be performed on the basis of a subset of patients, excluding those for whom major protocol deviations have been identified .However, these subanalyses may not serve as the basis for drawing conclusions concerning treatment efficacy, and the reasons for excluding patients from the analysis should be clearly reported. The 95% confidence intervals should also be provided.
Detailed description
Title: A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2 positive pretreated Breast Cancer. Protocol Code: IRST 174.01 Phase: Ib Study Design: open-label,single arm study in patients with advanced HER2 positive breast cancer.
Treatment Plan:
Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq \& Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq \& Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq \& Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq \& Lapatinib 1500 mg die. Three patients will be initially enrolled in each dose level starting from level 1. If none of the first triplet of patients will develop DLT, the dose will be escalated to the next level for the subsequent three patients. If one of the first triplets of patients will develop first-course DLT, a maximum of 3 additional patients will be entered at the same dose level. The MTD is defined as the dose below that at which two patients have experienced DLT. Lapatinib will be self-administered by the patient in an outpatient setting at the dose of the assigned step. Patients will take the drug daily by mouth on days 1 to 21 of each cycle. Caelyx will be administered by intravenous infusion over an exact period of 1 hour (preferably by a pump to guarantee a constant speed of infusion) on day
1 of each cycle repeated every 21 days.
Objectives:
Primary: to define the MTD and the safety profile of Lapatinib (Tyverb) plus Caelyx. Secondary: to preliminarily explore the anti tumour activity, to determine the objective tumor response rate using RECIST criteria.
Sample Size:
No formal sample size estimation is performed as this is primarily a descriptive phase I trial of safety and tolerability.
STATISTICAL METHODOLOGY:
Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their first treatment with Caelyx and Lapatinib. Evaluation of response: all patients included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible. Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data). All of the patients who met the eligibility criteria (with the possible exception of those who received no study medication) should be included in the main analysis of the response rate. Patients in response categories 4-9 should be considered as failing to respond to treatment (PD). Thus, an incorrect treatment schedule or drug administration does not result in exclusion from the analysis of the response rate.
All conclusions should be based on all eligible patients. Subanalyses may then be performed on the basis of a subset of patients, excluding those for whom major protocol deviations have been identified (e.g., early death due to other reasons, early discontinuation of treatment, major protocol violations, etc.). However, these subanalyses may not serve as the basis for drawing conclusions concerning treatment efficacy, and the reasons for excluding patients from the analysis should be clearly reported. The 95% confidence intervals should also be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lapatinib, Caelyx | Experimental | Drug: Lapatinib, Caelyx* Lapatinib is given at escalating doses orally and continuously on days 1-21. * Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Female patients with histologically or cytologically confirmed diagnosis of breast cancer.
- Locally advanced (Stage IIIb or Stage IIIc with T4 lesion) or metastatic (Stage IV) disease.
- Subjects must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry.
- Subjects must have disease progression (by RECIST) following prior therapy with taxane and trastuzumab-containing regimens (if not contraindicated).
- Patients may have had any number of prior chemotherapy, immunotherapy, hormonal therapy, investigational or radiotherapy regimens, but therapy must be discontinued at least 4 weeks before study entry (6 weeks if the last regimen included BCNU or mitomycin C).
Key exclusion criteria (8 listed)
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Prior treatment with Caelyx or Lapatinib.
- Previous malignancy except cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors, or other malignancies curatively treated > 3 years before study entry.
- Patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction, that would confound the evaluation of neurologic and other adverse events. Asymptomatic patients are allowed.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Caelyx and Lapatinib or other agents used in the study.
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, CaelyxAlso: Lapatinib, CaelyxLapatinib, Caelix: Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq \& Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq \& Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq \& Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq \& Lapatinib 1500 mg die | Drug | Lapatinib, Caelyx |
Primary outcome
MTD (Maximum Tolerated Dose)
Time frame: 6 years
The MTD (Maximum Tolerated Dose) is defined as the dose below that at which two patients have experienced DLT (Dose Limiting Toxicity).
2 secondary outcomes
Anti tumour activity of Lapatinib in combination with Caelyx in terms of Objective Response Rate (CR or PR).
Time frame: 6 years
Evaluation of toxicity.
Time frame: 6 years.
Results and safety
The study was stopped early (reason given: Safety reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Derived from this study: PubMed 28341957Rocca A, Cecconetto L, Passardi A, Melegari E, Andreis D, Monti M, Maltoni R, Sarti S, Pietri E, Schirone A, Fabbri F, Donati C, Nanni O, Fedeli A, Faedi M, Amadori D. Phase Ib dose-finding trial of lapatinib plus pegylated liposomal doxorubicin in advanced HER2-positive breast cancer. Cancer Chemother Pharmacol. 2017 May;79(5):863-871. doi: 10.1007/s00280-017-3279-8. Epub 2017 Mar 24.
Related trials for HER-2 Positive Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingObservational study
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
HR+/HER2- Early Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
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.
Dino Amadori, MD principal investigator
IRST IRCCS, Meldola
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lapatinib, Caelyx in people with HER-2 Positive Breast Cancer and Malignant Neoplasm of Breast, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
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 20 inclusion and 8 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: stopped early, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Safety reasons). Results are not available in the source record.
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?
MTD (Maximum Tolerated Dose) (time frame: 6 years). 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 NCT02131506, 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 2 Feb 2016.