Breast CancerPhase 2NCT01210768
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
A Phase 2 study testing Epirubicin+Cyclophosphamide and liposomal-doxorubicin+Cyclophosphamide in people with Breast Cancer, run by TTY Biopharm at 9 sites in Taiwan.
Trial summary
Primary objective: To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer Secondary objectives: To assess the overall survival (OS) To establish the safety profile by assessing the toxicities and tolerability To… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Epirubicin+Cyclophosphamide and liposomal-doxorubicin+Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 9 sitesTaiwan
- Study dates
- Jun 2010to 31 Oct 2022
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed invasive, but non-inflammatory, breast adenocarcinoma with stage I or II (if N0, T must be >1cm) disease
- Her2-negative on fluorescence in situ hybridization (FISH) study
- performance status of ECOG 0, 1
- female, age between 20 and 70 years
- life expectancy of at least one year
- ability to understand and willingness to sign a written informed consent document
Who cannot join
- Her2 3+ over-expression on immunohistochemistry (IHC), or Her2 amplification on fluorescence in situ hybridization (FISH) study
- previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years
- Patients who have received prior chemotherapy
- inadequate hematological function defined as absolute neutrophil count (ANC)less than 1,500/mm3, and platelets less than 100,000/mm3
- inadequate hepatic function defined as: serum bilirubin greater than 1.5 times the upper limit of normal range (ULN) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN
- inadequate renal function defined as serum creatinine greater than 1.5 times the ULN
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- left ventricular ejection fraction (LVEF) < 50% confirmed by multiple-gated acquisition (MUGA) scan or echocardiogram
- concomitant illness that might be aggregated by chemotherapy or interfere study assessment. For examples, active, non- controlled infection (such as hepatitis B and hepatitis C, HIV, infectious tuberculosis) or other active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia, unstable diabetes mellitus, and active peptic ulcer
- patients who are presence of liver cirrhosis or are HBV/HCV carrier
- participation in another clinical trial with any investigational drug within 30 days prior to entry
- pregnant or breast feeding women
- fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Taiwan9 sites
Changhua Christian Hospital
Changhua
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
Chang-Gung Memorial Hospital, Linkou
Linkou District
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
Official title: A Phase II Randomized Study of Pegylated Liposomal Doxorubicin, Cyclophosphamide Versus Epirubicin-Cyclophosphamide as Adjuvant Chemotherapy in Her2-negative Stage I and II Breast Cancer Patients
Primary objective:
- To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer
Secondary objectives:
- To assess the overall survival (OS)
- To establish the safety profile by assessing the toxicities and tolerability
- To assess the quality of life (QoL)
- To evaluate survival correlation with biomarkers expression.
- Conditions
- Breast Cancer
- Being tested
- Epirubicin+Cyclophosphamide, liposomal-doxorubicin+Cyclophosphamide
- Keywords
- Phase II, Pegylated Liposomal Doxorubicin, Adjuvant Chemotherapy, 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.
Epirubicin+CyclophosphamideDrug
Cyclophosphamide 600 mg/m2 infusion followed by epirubicin 90 mg/m2 infusion on Day 1 in each 21-day treatment cycle. Treatment will be repeated for 4 cycles in the EC arm.
liposomal-doxorubicin+CyclophosphamideDrug
Cyclophosphamide 600 mg/m2 infusion followed by pegylated liposomal-doxorubicin 37.5mg/m2 infusion on Day 1 in each 21-day treatment cycle. Treatment will be repeated for 5 cycles in the LC arm.
| Study group | Role | What they receive |
|---|---|---|
| EC | Active comparator | Cyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk Receives: Drug: Epirubicin+Cyclophosphamide |
| LC | Experimental | liposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk Receives: Drug: liposomal-doxorubicin+Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer
Measured: 5 years
Secondary outcomes (4)
Overall survival
Measured: 5 years
Quality of life
Measured: Baseline and every 3 weeks during therapy
Safety profiles
Incidence and severity of adverse event (neutropenia, palmar-plantar erythrodysesthesia, cardiac function, and secondary leukemia) by assessing the toxicities and tolerability
Measured: 5 years
Survival correlation with biomarkers expression
Measured: At approximately of 5 years maximum FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startJun 2010
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TTY Biopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming-Feng Hou, MD, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210768
- Sponsor's protocol ID
- TTYLD0914
- Status last verified
- Nov 2021
- First submitted
- 31 Aug 2010
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Pegylated Liposomal Doxorubicin, Cyclophosphamide Versus Epirubicin-Cyclophosphamide as Adjuvant Chemotherapy in Her2-negative Stage I and II Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01210768
- Acronym / sponsor ID
- TTYLD0914
- Conditions
- Breast Cancer
- Keywords
- Phase II, Pegylated Liposomal Doxorubicin, Adjuvant Chemotherapy, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- TTY BiopharmIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 28 Sep 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.
Primary objective:
- To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer
Secondary objectives:
- To assess the overall survival (OS)
- To establish the safety profile by assessing the toxicities and tolerability
- To assess the quality of life (QoL)
- To evaluate survival correlation with biomarkers expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EC | Active comparator | Drug: Epirubicin+CyclophosphamideCyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk |
| LC | Experimental | Drug: liposomal-doxorubicin+Cyclophosphamideliposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically confirmed invasive, but non-inflammatory, breast adenocarcinoma with stage I or II (if N0, T must be >1cm) disease
- Her2-negative on fluorescence in situ hybridization (FISH) study
- performance status of ECOG 0, 1
- female, age between 20 and 70 years
- life expectancy of at least one year
Key exclusion criteria (12 listed)
- Her2 3+ over-expression on immunohistochemistry (IHC), or Her2 amplification on fluorescence in situ hybridization (FISH) study
- previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years
- Patients who have received prior chemotherapy
- inadequate hematological function defined as absolute neutrophil count (ANC)less than 1,500/mm3, and platelets less than 100,000/mm3
- inadequate hepatic function defined as: serum bilirubin greater than 1.5 times the upper limit of normal range (ULN) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN
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 |
|---|---|---|
| Epirubicin+CyclophosphamideCyclophosphamide 600 mg/m2 infusion followed by epirubicin 90 mg/m2 infusion on Day 1 in each 21-day treatment cycle. Treatment will be repeated for 4 cycles in the EC arm. | Drug | EC |
| liposomal-doxorubicin+CyclophosphamideCyclophosphamide 600 mg/m2 infusion followed by pegylated liposomal-doxorubicin 37.5mg/m2 infusion on Day 1 in each 21-day treatment cycle. Treatment will be repeated for 5 cycles in the LC arm. | Drug | LC |
Primary outcome
Disease-free survival
Time frame: 5 years
To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer
4 secondary outcomes
Overall survival
Time frame: 5 years
Quality of life
Time frame: Baseline and every 3 weeks during therapy
Safety profiles
Time frame: 5 years
Survival correlation with biomarkers expression
Time frame: At approximately of 5 years maximum FU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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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.
Ming-Feng Hou, MD principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epirubicin+Cyclophosphamide and liposomal-doxorubicin+Cyclophosphamide in people with Breast Cancer, run by TTY Biopharm at 9 sites in Taiwan.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan. 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?
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?
Disease-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2021.