Breast CancerPhase 2NCT01472146
ZoNantax - Zolendronic Acid as Neoadjuvant Therapy Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
A Phase 2 study testing Zo-Nantax in people with Breast Cancer and Breast Disease, run by Susanne Crocamo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the association of zoledronic acid with standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER 2 positive. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Breast Disease, Neoplasms
- What is being tested?
- Zo-Nantax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to May 2017
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IIA to IIIB HER-2 positive breast cancer
- ECOG performance ≤ 2
- Adequate hematologic function with:
- Absolute neutrophil count (ANC)> 1500/mm³
- Platelets ≥ 100.000/mm³
- hemoglobin ≥ 9g/dL
Show all 14Show fewer
- Adequate hepatic and renal function with:
- Serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ 2.5 x the institutional upper limit of normal (ULN)
- Alkaline phosphatase )≤ 2.5 x the institutional upper limit of normal (ULN)
- Serum creatinine ≤ 1.5 x the institutional upper limit of normal (ULN) or calculated creatinine clearance > 50 mL/min
- Adequate cardiac function
- Left ventricular ejection fraction (LVEF)with institutional normal range
- Knowledge of the investigational nature of the study and ability to provide consent for study participation
Who cannot join
- Previous diagnostic of breast or other cancer
- Pregnancy
- Metastatic breast cancer
- Bilateral, synchronous breast cancer
- Any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that woud make the patient inappropriate for this study
- Neuropathy grade > 2 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Trial of Neoadjuvant Treatment With Zolendronic Acid Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
The purpose of this study is to evaluate the association of zoledronic acid with standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER 2 positive.
Read the detailed description
This trial combines zolendronic acid with anthracycline followed taxane plus trastuzumab for neoadjuvant treatment of HER 2 positive stage II/III breast cancer.
Zoledronic acid (ZOL) has activity of anti-bone resorption and shows diverse anti-tumor effects in vitro. Some chemical and biological characteristics of ZOL indicate potential for inhibition of tumor growth in pre clinical studies
The primary objective of the study is to evaluate the residual cancer burden (RCB) with the addition of zolendronic acid to standard neoadjuvant therapy. RCB is calculated as a continuous index combining pathologic measurements of primary tumor (size and cellularity) and nodal metastases (number and size). RCB index is a significant predictor of distant relapse-free survival, and can be used to define categories of near-complete response and chemotherapy resistance after neoadjuvant chemotherapy compared with currently used risk factors. Additionally, the study will collect tissue biopsies and blood before and after treatment in order to correlate clinical outcomes with gene expression and radiologic data to predictive response.
- Conditions
- Breast Cancer, Breast Disease, Neoplasms, Neoplasms by Site
- Being tested
- Zo-Nantax
- Keywords
- Neoadjuvant therapy, Breast cancer HER2 positive, zolendronic acid
- Medical subject headings
- Breast Neoplasms, Breast Diseases, Neoplasms, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zo-NantaxDrug
Also called Other Names:, Adriblastine RD, Cytoxan, Taxotere®
Experimental:
AC,Docetaxel,Trastuzumab,Zolendronate
Drug: AC Adriamycin 60mg/m2 IV plus cyclophosphamide 600mg/m2 every 21 days for 4 cycles
Drug: Docetaxel
Docetaxel 100 mg/m2 every 21 days for 4 cycles.
Drug: Trastuzumab
Trastuzumab 8mg/kg [loading dose] once then 6mg/kg IV every 21 days for 3 cycles plus docetaxel.
Drug: zolendronic acid
Zolendronic acid 4mg IV every 21 days for 8 cycles combine with chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Zometa neoadjuvant HER2 breast cancer | Experimental | Zo-Nantax arm - Neoadjuvant chemotherapy with association of zoledronic acid and standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER2 positive HR positive/negative.
Drug:Cyclophosphamide Drug:Adriamycin Drug:Docetaxel Drug:Trastuzumab Drug:Zolendronic acid Receives: Drug: Zo-Nantax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the residual cancer burden (RCB)
Use MD Anderson calculator to quantify the minimal residual disease
Measured: 6 months
Secondary outcomes (3)
Assessing the tolerance to standard neoadjuvant treatment plus zolendronic acid,according to the common toxicity criteria Terminology Criteria for Adverse Events version 3.0.
CTC 4.0
Measured: 6 months
Assessment of the difference in gene expression according to treatment response
Through microarray assays
Measured: 6 months
Prediction of pathological response by MRI calculated from the sequence of apparent diffusion coefficient (ADC)
Make MRI before the start of chemotherapy, after the second cycle and before surgery, and evaluate the changes in the diffusion of water
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2016
- Study completionMay 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Crocamo
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Susanne Crocamo, Instituto Nacional de Cancer, Brazil
- Investigators
- Susanne C Costa, MD, Principal investigator, Hospital do Cancer III - INCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472146
- Sponsor's protocol ID
- Zo-neo2011
- Status last verified
- May 2017
- First submitted
- 20 Sep 2011
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: I don't plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Neoadjuvant Treatment With Zolendronic Acid Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01472146
- Acronym / sponsor ID
- Zo-neo2011
- Conditions
- Breast Cancer, Breast Disease, Neoplasms, Neoplasms by Site
- Keywords
- Neoadjuvant therapy, Breast cancer HER2 positive, zolendronic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Susanne CrocamoOther government
- Study start
- Oct 2011 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Nov 2011 (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 purpose of this study is to evaluate the association of zoledronic acid with standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER 2 positive.
Detailed description
This trial combines zolendronic acid with anthracycline followed taxane plus trastuzumab for neoadjuvant treatment of HER 2 positive stage II/III breast cancer.
Zoledronic acid (ZOL) has activity of anti-bone resorption and shows diverse anti-tumor effects in vitro. Some chemical and biological characteristics of ZOL indicate potential for inhibition of tumor growth in pre clinical studies
The primary objective of the study is to evaluate the residual cancer burden (RCB) with the addition of zolendronic acid to standard neoadjuvant therapy. RCB is calculated as a continuous index combining pathologic measurements of primary tumor (size and cellularity) and nodal metastases (number and size). RCB index is a significant predictor of distant relapse-free survival, and can be used to define categories of near-complete response and chemotherapy resistance after neoadjuvant chemotherapy compared with currently used risk factors. Additionally, the study will collect tissue biopsies and blood before and after treatment in order to correlate clinical outcomes with gene expression and radiologic data to predictive response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zometa neoadjuvant HER2 breast cancer | Experimental | Drug: Zo-NantaxZo-Nantax arm - Neoadjuvant chemotherapy with association of zoledronic acid and standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER2 positive HR positive/negative. Drug:Cyclophosphamide Drug:Adriamycin Drug:Docetaxel Drug:Trastuzumab Drug:Zolendronic acid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Stage IIA to IIIB HER-2 positive breast cancer
- ECOG performance ≤ 2
- Adequate hematologic function with:
- Adequate hepatic and renal function with:
- Adequate cardiac function
Key exclusion criteria (6 listed)
- Previous diagnostic of breast or other cancer
- Pregnancy
- Metastatic breast cancer
- Bilateral, synchronous breast cancer
- Any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that woud make the patient inappropriate for this 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 |
|---|---|---|
| Zo-NantaxAlso: Other Names:, Adriblastine RD, Cytoxan, Taxotere®Experimental: AC,Docetaxel,Trastuzumab,Zolendronate Drug: AC Adriamycin 60mg/m2 IV plus cyclophosphamide 600mg/m2 every 21 days for 4 cycles Drug: Docetaxel Docetaxel 100 mg/m2 every 21 days for 4 cycles. Drug: Trastuzumab Trastuzumab 8mg/kg [loading dose] once then 6mg/kg IV every 21 days for 3 cycles plus docetaxel. Drug: zolendronic acid Zolendronic acid 4mg IV every 21 days for 8 cycles combine with chemotherapy | Drug | Zometa neoadjuvant HER2 breast cancer |
Primary outcome
Evaluate the residual cancer burden (RCB)
Time frame: 6 months
Use MD Anderson calculator to quantify the minimal residual disease
3 secondary outcomes
Assessing the tolerance to standard neoadjuvant treatment plus zolendronic acid,according to the common toxicity criteria Terminology Criteria for Adverse Events version 3.0.
Time frame: 6 months
Assessment of the difference in gene expression according to treatment response
Time frame: 6 months
Prediction of pathological response by MRI calculated from the sequence of apparent diffusion coefficient (ADC)
Time frame: 4 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 9 May 2017.
- Individual participant dataSharing planned: No. I don't plan to share IPD
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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.
Susanne C Costa, MD principal investigator
Hospital do Cancer III - INCA
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 Zo-Nantax in people with Breast Cancer and Breast Disease, run by Susanne Crocamo at 1 site in Brazil.
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 14 inclusion and 6 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 9 May 2017. 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 Brazil. 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?
Evaluate the residual cancer burden (RCB) (time frame: 6 months). 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 9 May 2017.