Breast CancerPhase 2EndoTAG-1NCT01537536
Trial of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in HER2-negative Breast Cancer
A Phase 2 study testing EndoTAG-1 in people with Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of weekly paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- EndoTAG-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2011to Nov 2012
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed histologically confirmed BC with breast infiltrating carcinoma of histological grade > 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy
- HER2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (FISH)
- ECOG performance status 0 or 1
- Gender: female
- Age : >= 18 years old
- Negative pregnancy test (females of childbearing potential)
- Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential)
- Signed informed consent
Who cannot join
- Metastatic or relapsed disease
- Major surgery < 3 weeks prior to enrollment
- Severe pulmonary obstructive or restrictive disease
- Uncontrolled inflammatory disease (autoimmune or infectious)
- Clinically significant cardiac disease (NYHA stadium > 2)
- Results of laboratory tests (hematology, chemistry) outside specified limits:
Show all 20Show fewer
- WBC ≤ 3 x 109/L
- ANC < 1.5 x 109/L
- Platelets < 100 x 109/L
- Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
- PTT/ INR > 1.5 x ULN
- AST or ALT > 2.5 x ULN
- Alkaline Phosphatase > 2 x ULN
- Total Bilirubin > 1.5 x ULN
- Pregnancy or nursing status
- Known positive HIV testing
- Known hypersensitivity to any component of the EndoTAG-1, paclitaxel or FEC formulations
- History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
- History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
- Concurrent treatment with other experimental products. Participation in another clinical trial with any investigational product within 30 days prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in Patients With HER2-negative Breast Cancer
The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of weekly paclitaxel. This is a prospective single-center study that will investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant chemotherapy).
Read the detailed description
This is a prospective, single-center, open-label phase II clinical trial investigating the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative BC candidate for neoadjuvant chemotherapy, as measured by the decrease in MRI-estimated tumour volume at the end of EndoTAG-1 + paclitaxel administration. Patients will be stratified by hormone receptor status.
A total of 20 female patients with non-metastatic HER2-negative breast cancer candidate for neoadjuvant chemotherapy and meeting all study eligibility criteria will receive 12 weekly infusions of EndoTAG-1 (22 mg/m2 liposomal paclitaxel) in combination with paclitaxel (70 mg/m2) followed by 3 cycles of FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) every 3 weeks (experimental group) The study hypothesis is that EndoTAG-1 will improve MRI- estimated volume reduction when added to weekly paclitaxel. The null hypothesis is that combination has no or a negligible effect on volume reduction (defined as lower or equal to a 50% decrease) versus the alternative hypothesis that the combination yields at least a 80% average decrease in MRI- estimated volume at the end of weekly paclitaxel and EndoTAG-1 administration from baseline
- Conditions
- Breast Cancer
- Being tested
- EndoTAG-1
- Keywords
- Breast cancer, Neoadjuvant chemotherapy, EndoTAG-1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoTAG-1Drug
Also called Non applicable
EndoTAG-1 (22 mg/m2 liposomal paclitaxel) + Paclitaxel (70 mg/m2) Weekly i.v. infusions of EndoTAG-1 and paclitaxel for 12 weeks followed by subsequent treatment with the standard FEC regimen (Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) once every 3 weeks for 3 cycles of therapy followed by surgery.
| Study group | Role | What they receive |
|---|---|---|
| EndoTAG-1 | Experimental | Weekly treatment with EndoTAG-1 (22 mg/m2) plus paclitaxel (70 mg/m2) for 12 weeks (ET+P) followed by subsequent treatment with the standard FEC regimen (Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) once every 3 weeks for 3 cycles of therapy followed by surgery. Receives: Drug: EndoTAG-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline.
To investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative BC candidate for neoadjuvant chemotherapy, as measured by the decrease in MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline.
Measured: 15 weeks after start of neoadjuvant chemotherapy.
Secondary outcomes (1)
Rate of pathological complete response (pCR).
Rate of pathological complete response (pCR) at the end of neo-adjuvant chemotherapy.
Measured: 27 weeks after start of neoadjuvant chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionNov 2012
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michail Ignatiadis, MD, PhD, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537536
- Sponsor's protocol ID
- IJBNeoEndoTAG-1
- Acronym
- EndoTAG-1
- Status last verified
- Feb 2012
- First submitted
- 20 Sep 2011
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ignatiadis M, Zardavas D, Lemort M, Wilke C, Vanderbeeken MC, D'Hondt V, De Azambuja E, Gombos A, Lebrun F, Dal Lago L, Bustin F, Maetens M, Ameye L, Veys I, Michiels S, Paesmans M, Larsimont D, Sotiriou C, Nogaret JM, Piccart M, Awada A. Feasibility Study of EndoTAG-1, a Tumor Endothelial Targeting Agent, in Combination with Paclitaxel followed by FEC as Induction Therapy in HER2-Negative Breast Cancer. PLoS One. 2016 Jul 25;11(7):e0154009. doi: 10.1371/journal.pone.0154009. eCollection 2016.
PubMed 27454930
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in Patients With HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01537536
- Acronym / sponsor ID
- EndoTAG-1 / IJBNeoEndoTAG-1
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Neoadjuvant chemotherapy, EndoTAG-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Feb 2012 (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.
The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of weekly paclitaxel. This is a prospective single-center study that will investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant chemotherapy).
Detailed description
This is a prospective, single-center, open-label phase II clinical trial investigating the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative BC candidate for neoadjuvant chemotherapy, as measured by the decrease in MRI-estimated tumour volume at the end of EndoTAG-1 + paclitaxel administration. Patients will be stratified by hormone receptor status.
A total of 20 female patients with non-metastatic HER2-negative breast cancer candidate for neoadjuvant chemotherapy and meeting all study eligibility criteria will receive 12 weekly infusions of EndoTAG-1 (22 mg/m2 liposomal paclitaxel) in combination with paclitaxel (70 mg/m2) followed by 3 cycles of FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) every 3 weeks (experimental group) The study hypothesis is that EndoTAG-1 will improve MRI- estimated volume reduction when added to weekly paclitaxel. The null hypothesis is that combination has no or a negligible effect on volume reduction (defined as lower or equal to a 50% decrease) versus the alternative hypothesis that the combination yields at least a 80% average decrease in MRI- estimated volume at the end of weekly paclitaxel and EndoTAG-1 administration from baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoTAG-1 | Experimental | Drug: EndoTAG-1Weekly treatment with EndoTAG-1 (22 mg/m2) plus paclitaxel (70 mg/m2) for 12 weeks (ET+P) followed by subsequent treatment with the standard FEC regimen (Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) once every 3 weeks for 3 cycles of therapy followed by surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- newly diagnosed histologically confirmed BC with breast infiltrating carcinoma of histological grade > 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy
- HER2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (FISH)
- ECOG performance status 0 or 1
- Gender: female
- Age : >= 18 years old
Key exclusion criteria (20 listed)
- Metastatic or relapsed disease
- Major surgery < 3 weeks prior to enrollment
- Severe pulmonary obstructive or restrictive disease
- Uncontrolled inflammatory disease (autoimmune or infectious)
- Clinically significant cardiac disease (NYHA stadium > 2)
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 |
|---|---|---|
| EndoTAG-1Also: Non applicableEndoTAG-1 (22 mg/m2 liposomal paclitaxel) + Paclitaxel (70 mg/m2) Weekly i.v. infusions of EndoTAG-1 and paclitaxel for 12 weeks followed by subsequent treatment with the standard FEC regimen (Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) once every 3 weeks for 3 cycles of therapy followed by surgery. | Drug | EndoTAG-1 |
Primary outcome
MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline.
Time frame: 15 weeks after start of neoadjuvant chemotherapy.
To investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative BC candidate for neoadjuvant chemotherapy, as measured by the decrease in MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline.
1 secondary outcome
Rate of pathological complete response (pCR).
Time frame: 27 weeks after start of neoadjuvant chemotherapy.
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 17 Jun 2013.
- Derived from this study: PubMed 27454930Ignatiadis M, Zardavas D, Lemort M, Wilke C, Vanderbeeken MC, D'Hondt V, De Azambuja E, Gombos A, Lebrun F, Dal Lago L, Bustin F, Maetens M, Ameye L, Veys I, Michiels S, Paesmans M, Larsimont D, Sotiriou C, Nogaret JM, Piccart M, Awada A. Feasibility Study of EndoTAG-1, a Tumor Endothelial Targeting Agent, in Combination with Paclitaxel followed by FEC as Induction Therapy in HER2-Negative Breast Cancer. PLoS One. 2016 Jul 25;11(7):e0154009. doi: 10.1371/journal.pone.0154009. eCollection 2016.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative 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
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.
Michail Ignatiadis, MD, PhD principal investigator
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EndoTAG-1 in people with Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
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 8 inclusion and 20 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 17 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 1 site in Belgium. 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?
MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline. (time frame: 15 weeks after start of neoadjuvant chemotherapy.). 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 NCT01537536, 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 17 Jun 2013.