Breast CancerPhase 2NCT00503906
Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer
A Phase 2 study testing Avastin, Gemcitabine and Abraxane in people with Breast Cancer, run by University of Miami at 1 site in United States.
Trial summary
The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will increase the progression-free survival (PFS) in patients with first line metastatic breast cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with definable metastatic disease, 6 or more months… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Avastin, Gemcitabine and Abraxane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must either be:
- treatment-naïve with newly diagnosed her2neu non-overexpressing (non amplified) metastatic (Stage IV) breast cancer, or
- HER2/neu-negative patients with metastasis diagnosed 6 or more months after completing primary systemic treatment (neoadjuvant, adjuvant chemotherapy).
- No previous chemotherapy regimen for metastatic breast cancer.
- 18 years of age or older.
- Measurable disease as defined by RECIST criteria or evaluable disease.
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- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Life expectancy greater than 3 months.
- For female (or male) patients, either pre- or post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study
- Provide written informed consent before any study-related procedure not part of normal medical care is conducted
- Willing and able to comply with the protocol requirement
- Laboratory parameters as follows:
- Neutrophils: 1.5 x109/L or greater
- Platelets: 100 x109/L or greater
- Hemoglobin: ≥ 9.0 g/dL
- Serum Creatinine: ≤ 1.5mg/dL
- Bilirubin: ≤ ULN, except when caused by metastatic disease
- Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times the upper limit of the normal range (ULN) except when caused by metastatic disease
- Urine protein creatinine (UPC) ratio < 1.0 at screening.
Who cannot join
- Previous treatment with gemcitabine.
- History of Gastrointestinal Bleeding in the previous 3 months.
- Chemotherapy within 4 weeks prior to enrollment.
- Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
- Any major surgery within 4 weeks prior to enrollment.
- Presence of central nervous system or brain metastases.
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- Urine protein: creatinine ratio ≥ 1.0 at screening.
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
- A prior history of hypertensive crisis or hypertensive encephalopathy.
- Peripheral neuropathy > grade I.
- Clinical AIDS or known positive HIV serology
- No concurrent clinically evident malignancy is allowed except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years.
- Unstable angina.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months.
- History of stroke within 6 months.
- Clinically significant peripheral vascular disease.
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to enrollment.
- Pregnant (positive pregnancy test) or lactating.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Inability to comply with study and/or follow-up procedures
- Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
- Participants cannot have been in another experimental drug study other than a Bevacizumab cancer study within 4 weeks of the first infusion of these study medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Abraxane, Avastin and Gemcitabine for First Line Metastatic Breast Cancer
The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will increase the progression-free survival (PFS) in patients with first line metastatic breast cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with definable metastatic disease, 6 or more months after primary treatment.
Read the detailed description
This is a phase 2, single arm study. Participants will be treated with combination Gemzar, Abraxane and Avastin therapy until disease progression. Each treatment cycle is 28 days.
- Conditions
- Breast Cancer
- Being tested
- Avastin, Gemcitabine, Abraxane
- Keywords
- stage IV breast cancer, recurrent 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.
AvastinDrug
Also called Bevacizumab
GemcitabineDrug
Also called Gemzar
AbraxaneDrug
Also called Albumin-Bound Paclitaxel Formulation
| Study group | Role | What they receive |
|---|---|---|
| Abraxane, Avastin and Gemcitabine | Experimental | Each treatment cycle is 28 days. Participants will be treated until disease progression:
* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle. Receives: Drug: Avastin; Drug: Gemcitabine; Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-Free Survival
Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.
Measured: Up to 24 months
Secondary outcomes (4)
Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants
Rates of partial response (PR), complete response (CR) and overall response (PR+CR = ORR) in study participants according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.
Measured: After two cycles, about 60 days
Rate of Toxicity in Study Participants
Determination of safety and side effect profile of the protocol therapy including the rate of toxicity in study participants. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.
Measured: Over the course of study treatment.
Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment
Exploration of the relationship between circulating tumor cells (CTC) and disease progression, by measuring CTC at baseline and over the course of treatment.
Measured: Baseline, over the course of Treatment, about 1 year
Relationship Between SPARC Expression and Response to Protocol Therapy.
Relationship between SPARC expression and response to this chemotherapy combination and relation to progression free survival.
Measured: Baseline, over the course of treatment, about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Glück, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503906
- Sponsor's protocol ID
- 20060913
- Other IDs
- SCCC-2006081
- Status last verified
- May 2017
- First submitted
- 17 Jul 2007
- Last updated
- 12 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lobo C, Lopes G, Baez O, Castrellon A, Ferrell A, Higgins C, Hurley E, Hurley J, Reis I, Richman S, Seo P, Silva O, Slingerland J, Tukia K, Welsh C, Gluck S. Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer. Breast Cancer Res Treat. 2010 Sep;123(2):427-35. doi: 10.1007/s10549-010-1002-0. Epub 2010 Jun 29.
PubMed 20585851
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Abraxane, Avastin and Gemcitabine for First Line Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00503906
- Acronym / sponsor ID
- 20060913
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Posted 2 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will increase the progression-free survival (PFS) in patients with first line metastatic breast cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with definable metastatic disease, 6 or more months after primary treatment.
Detailed description
This is a phase 2, single arm study. Participants will be treated with combination Gemzar, Abraxane and Avastin therapy until disease progression. Each treatment cycle is 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abraxane, Avastin and Gemcitabine | Experimental | Drug: Avastin, Drug: Gemcitabine, Drug: AbraxaneEach treatment cycle is 28 days. Participants will be treated until disease progression: * Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Avastin: 10 mg/kg IV on days 1 and 15 of each cycle. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must either be:
- No previous chemotherapy regimen for metastatic breast cancer.
- 18 years of age or older.
- Measurable disease as defined by RECIST criteria or evaluable disease.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
Key exclusion criteria (26 listed)
- Previous treatment with gemcitabine.
- History of Gastrointestinal Bleeding in the previous 3 months.
- Chemotherapy within 4 weeks prior to enrollment.
- Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
- Any major surgery within 4 weeks prior to enrollment.
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 |
|---|---|---|
| AvastinAlso: Bevacizumab | Drug | Abraxane, Avastin and Gemcitabine |
| GemcitabineAlso: Gemzar | Drug | Abraxane, Avastin and Gemcitabine |
| AbraxaneAlso: Albumin-Bound Paclitaxel Formulation | Drug | Abraxane, Avastin and Gemcitabine |
Primary outcome
Median Progression-Free Survival
Time frame: Up to 24 months
Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.
4 secondary outcomes
Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants
Time frame: After two cycles, about 60 days
Rate of Toxicity in Study Participants
Time frame: Over the course of study treatment.
Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment
Time frame: Baseline, over the course of Treatment, about 1 year
Relationship Between SPARC Expression and Response to Protocol Therapy.
Time frame: Baseline, over the course of treatment, about 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20585851Lobo C, Lopes G, Baez O, Castrellon A, Ferrell A, Higgins C, Hurley E, Hurley J, Reis I, Richman S, Seo P, Silva O, Slingerland J, Tukia K, Welsh C, Gluck S. Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer. Breast Cancer Res Treat. 2010 Sep;123(2):427-35. doi: 10.1007/s10549-010-1002-0. Epub 2010 Jun 29.
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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.
Stefan Glück, MD, PhD principal investigator
University of Miami
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 Avastin, Gemcitabine and Abraxane in people with Breast Cancer, run by University of Miami at 1 site in United States.
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 19 inclusion and 26 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 12 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Progression-Free Survival (time frame: Up to 24 months). 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 NCT00503906, 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 12 May 2017.