Breast CancerNCT02637375
A Pilot Preoperative Trial of Ganetespib With Paclitaxel for Triple-Negative Breast Cancer
A study testing Ganetespib, Paclitaxel and Doxorubicin in people with Breast Cancer, run by University of Chicago.
Trial summary
Based on preclinical data implicating GR, AR, and JAK/STAT activation as potent mechanisms of breast cancer cell survival despite chemotherapy administration (i.e. chemotherapy resistance), the study will test a novel approach for improving chemotherapy effectiveness by adding Hsp90 inhibition to antagonize the… 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?
- Ganetespib, Paclitaxel and Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2018
- Phase
- Interventional
- 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
- Invasive carcinoma of the breast
- ER negative and PR negative tumors defined as < 1% of tumor nuclei that are immunoreactive for ER and PR
- HER2 non-overexpressing status documented as:
- FISH ratio of less than 2.0, OR
- IHC staining of 0 or 1+
- No evidence of distant metastatic disease. Patients with regional lymph node involvement are eligible.
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- >18 years old
- Female
- No prior treatment for the disease under study
- No prior treatment within 5 years for any other cancer including chemotherapy, surgery (except for diagnostic biopsy), radiotherapy, hormonal therapy, or investigational agents, unless curative treatment of non-melanoma skin-cancer or in-situ cancer
- Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 2cm
- Willing to undergo three mandatory core biopsies after diagnosis to obtain tissue for biologic expression profiling.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Adequate bone marrow reserves as evidenced by:
- Leukocytes > 3,000/μL
- Absolute neutrophil count (ANC) > 1,500/μL without the use of hematopoietic growth factors,
- Platelet count > 100,000/μL, and
- Hemoglobin > 9 g/dL
- Adequate hepatic function as evidenced by:
- Serum total bilirubin within institutional normal limits
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase less than or equal to 2.5 × ULN
- Adequate renal function as evidenced by a serum creatinine within ULN or creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide
- If of childbearing potential, are willing to abstain from sexual intercourse or to use an effective form of contraception (e.g., a double-barrier method) during the study and for 90 days following the last dose of ganetespib
Who cannot join
- • Patients may not be receiving any other investigational agents.
- Patients may not have a known hypersensitivity to any of the components of ganetespib
- Patients may not have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL.
- Patients with a QTc > 470 ms, a family history of long QT Syndrome, and those on medications known to cause Torsades de Pointes will be excluded from the study.
- Patients may not have an 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.
- Patients may not have New York Heart Association (NYHA) Class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50%.
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- As patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study.
- Patients may not have a need for chronic systemic steroid therapy
- Patients may not be pregnant or breastfeeding
About this study
Based on preclinical data implicating GR, AR, and JAK/STAT activation as potent mechanisms of breast cancer cell survival despite chemotherapy administration (i.e. chemotherapy resistance), the study will test a novel approach for improving chemotherapy effectiveness by adding Hsp90 inhibition to antagonize the anti-apoptotic signaling pathways that are initiated via GR, AR, and JAK/STAT activation.
Read the detailed description
STUDY OBJECTIVES
Primary:
- To determine tumor GR, AR, JAK and other Hsp90 client protein expression before and after two weeks of ganetespib monotherapy
Secondary:
- To determine the pathological Complete Response (pCR) rate associated with weekly treatment of ganetespib plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide
- To characterize the toxicity of study treatment
- Conditions
- Breast Cancer
- Being tested
- Ganetespib, Paclitaxel, Doxorubicin, Cyclophosphamide
- Keywords
- triple-negative breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanetespibDrug
PaclitaxelDrug
DoxorubicinDrug
CyclophosphamideDrug
| Study group | Role | What they receive |
|---|---|---|
| Therapy | Experimental | Patients will receive ganetespib monotherapy for two weeks followed by twelve weeks of ganetespib/paclitaxel therapy followed by 4 bi-weekly doses of doxorubicin/cyclophosphamide therapy followed by surgery. Receives: Drug: Ganetespib; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GR protein
Measured: 2 weeks
Secondary outcomes (2)
Pathological Complete Response (pCR) rate
Defined as absence of invasive carcinoma in both the breast and axilla at the time of surgery
Measured: 6 month
Ganetespib toxicity
Side effects related to Ganetespib as graded per Common Terminology Criteria for Adverse Events (CTCAE) version 4
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Study never opened (terminated as study drug no longer available)
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.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Nanda, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637375
- Sponsor's protocol ID
- IRB15-0848
- Status last verified
- May 2016
- First submitted
- 17 Dec 2015
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Preoperative Trial of Ganetespib With Paclitaxel for Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02637375
- Acronym / sponsor ID
- IRB15-0848
- Conditions
- Breast Cancer
- Keywords
- triple-negative breast cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never opened (terminated as study drug no longer available)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Dec 2015 (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.
Based on preclinical data implicating GR, AR, and JAK/STAT activation as potent mechanisms of breast cancer cell survival despite chemotherapy administration (i.e. chemotherapy resistance), the study will test a novel approach for improving chemotherapy effectiveness by adding Hsp90 inhibition to antagonize the anti-apoptotic signaling pathways that are initiated via GR, AR, and JAK/STAT activation.
Detailed description
STUDY OBJECTIVES
Primary:
- To determine tumor GR, AR, JAK and other Hsp90 client protein expression before and after two weeks of ganetespib monotherapy
Secondary:
- To determine the pathological Complete Response (pCR) rate associated with weekly treatment of ganetespib plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide
- To characterize the toxicity of study treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy | Experimental | Drug: Ganetespib, Drug: Paclitaxel, Drug: Doxorubicin, Drug: CyclophosphamidePatients will receive ganetespib monotherapy for two weeks followed by twelve weeks of ganetespib/paclitaxel therapy followed by 4 bi-weekly doses of doxorubicin/cyclophosphamide 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 (25 listed)
- Invasive carcinoma of the breast
- ER negative and PR negative tumors defined as < 1% of tumor nuclei that are immunoreactive for ER and PR
- HER2 non-overexpressing status documented as:
- FISH ratio of less than 2.0, OR
- IHC staining of 0 or 1+
Key exclusion criteria (9 listed)
- • Patients may not be receiving any other investigational agents.
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 |
|---|---|---|
| Ganetespib | Drug | Therapy |
| Paclitaxel | Drug | Therapy |
| Doxorubicin | Drug | Therapy |
| Cyclophosphamide | Drug | Therapy |
Primary outcome
Change in GR protein
Time frame: 2 weeks
2 secondary outcomes
Pathological Complete Response (pCR) rate
Time frame: 6 month
Ganetespib toxicity
Time frame: 14 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
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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.
Rita Nanda, MD principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Ganetespib, Paclitaxel and Doxorubicin in people with Breast Cancer, run by University of Chicago.
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 25 inclusion and 9 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: withdrawn, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in GR protein (time frame: 2 weeks). 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 30 May 2016.