Breast CancerPhase 2NCT00193206

Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

A Phase 2 study testing Gemcitabine, Epirubicin and Albumin-bound Paclitaxel in people with Breast Cancer, run by SCRI Development Innovations, LLC at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet. 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?: Gemcitabine, Epirubicin and Albumin-bound Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 13 sitesUnited States
Study dates: Sep 2005to May 2009
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

To be included in this study, you must meet the following criteria:
Locally advanced/inflammatory adenocarcinoma of the breast
18 years of age or older
Normal heart function
Able to perform activities of daily living with minimal assistance
No prior chemotherapy for breast cancer

Show all 10Show fewer

Adequate bone marrow, liver and kidney function
No evidence or history of significant cardiovascular abnormalities
Sentinel node or axillary dissection
Sign an informed consent form

Who cannot join

You cannot participate in this study if any of the following apply to you:
Pregnant or breast feeding
History of heart disease with congestive heart failure
Heart attack within the previous 6 months
Prior chemotherapy or hormone therapy for breast cancer
History of active uncontrolled infection
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Hematology Oncology Life Center
Alexandria, Louisiana, 71301
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, 37404
Oncology Hematology Care
Cincinnati, Ohio, 45242
Florida Cancer Specialists
Fort Myers, Florida, 33901
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Integrated Community Oncology Network
Jacksonville, Florida, 32256
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207
Tennessee Oncology
Nashville, Tennessee, 37203
Peninsula Cancer Institute
Newport News, Virginia, 23601
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Mercy Hospital
Portland, Maine, 04101
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303

Other trials in United States

About this study

Official title: Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

Read the detailed description

Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen:

Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim

Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim

Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.

Conditions: Breast Cancer
Being tested: Gemcitabine, Epirubicin, Albumin-bound Paclitaxel
Keywords: Locally Advanced Breast Cancer, Inflammatory Breast Cancer, Breast Cancer, Abraxane, nab Paclitaxel, Epirubicin, Gemcitabine, Gemzar
Medical subject headings: Breast Neoplasms, Inflammatory Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GemcitabineDrug
Also called Systemic therapy, Gemzar
Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
EpirubicinDrug
Also called Systemic therapy, Ellence
Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
Albumin-bound PaclitaxelDrug
Also called Systemic therapy, ABI-007, Abraxane
ABI-007 175 mg/m2 D1 q 14 days x 6 cycles

Study groups in NCT00193206
Study group	Role	What they receive
Intervention	Experimental	Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy. Receives: Drug: Gemcitabine; Drug: Epirubicin; Drug: Albumin-bound Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Pathologic Complete Response
For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
Measured: 18 months

Secondary outcomes (3)

Clinical Response Rates
Clinical response rate is defined as percentage of patients whose disease decreased (Partial response - PR) and/or disappeared (Complete response - CR) after treatment). Clinical tumor response was defined as complete if there was no clinical evidence of palpable tumor in either the breast or axilla at the time of surgery. Reduction of total tumor size >50 % at the time surgery was considered a clinical partial response. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 18 months
Time to Disease Progression
Time to progression is the length of time from the start of treatment until the disease progressed. Progressive disease is defined as an increase of >25% in the total calculated product of the tumor's measurements or development of a new lesion. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 36 months
Rates of Breast Preservation
Number of patients who underwent breast conservation after neo adjuvant chemotherapy
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005May 2009

First posted19 Sep 2005 (estimated)
Study startSep 2005
Primary completionOct 2008
Study completionMay 2009

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.
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: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00193206
Sponsor's protocol ID: SCRI BRE 73
Status last verified: Nov 2021
First submitted: 12 Sep 2005
Last updated: 23 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Yardley DA, Zubkus J, Daniel B, Inhorn R, Lane CM, Vazquez ER, Naot Y, Burris HA 3rd, Hainsworth JD. A phase II trial of dose-dense neoadjuvant gemcitabine, epirubicin, and albumin-bound paclitaxel with pegfilgrastim in the treatment of patients with locally advanced breast cancer. Clin Breast Cancer. 2010 Oct 1;10(5):367-72. doi: 10.3816/CBC.2010.n.048.
PubMed 20670921

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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: Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
ClinicalTrials.gov ID: NCT00193206
Acronym / sponsor ID: SCRI BRE 73
Conditions: Breast Cancer
Keywords: Locally Advanced Breast Cancer, Inflammatory Breast Cancer, Breast Cancer, Abraxane, nab Paclitaxel, Epirubicin, Gemcitabine, Gemzar
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: SCRI Development Innovations, LLCUniversity, hospital or other
Collaborators: Eli Lilly and Company, Celgene Corporation
Study start: Sep 2005
Primary completion: Oct 2008 (actual)
Study completion: May 2009 (actual)
First posted: 19 Sep 2005 (estimated)
Results: Posted 30 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen:

Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim

Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim

Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention	Experimental	Drug: Gemcitabine, Drug: Epirubicin, Drug: Albumin-bound PaclitaxelPatients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Locally advanced/inflammatory adenocarcinoma of the breast
18 years of age or older
Normal heart function
Able to perform activities of daily living with minimal assistance
No prior chemotherapy for breast cancer

Key exclusion criteria (7 listed)

Pregnant or breast feeding
History of heart disease with congestive heart failure
Heart attack within the previous 6 months
Prior chemotherapy or hormone therapy for breast cancer
History of active uncontrolled infection

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
GemcitabineAlso: Systemic therapy, GemzarGemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles	Drug	Intervention
EpirubicinAlso: Systemic therapy, EllenceEpirubicin 50 mg/m2 D1 q 14 days x 6 cycles	Drug	Intervention
Albumin-bound PaclitaxelAlso: Systemic therapy, ABI-007, AbraxaneABI-007 175 mg/m2 D1 q 14 days x 6 cycles	Drug	Intervention

Primary outcome

Pathologic Complete Response
Time frame: 18 months
For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.

3 secondary outcomes

Clinical Response Rates
Time frame: 18 months
Time to Disease Progression
Time frame: 36 months
Rates of Breast Preservation
Time frame: 18 months

Results and safety

Results posted to the registry on 30 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	123	116

Primary outcome: Pathologic Complete Response

Time frame: 18 months. Count of participants. Unit: Participants

Measure	Intervention n = 116
Value	23

Population analysed: 7 patients did not complete the study. Only the patients who had surgical procedures following neoadjuvant chemotherapy were included in the analysis as pathologic complete response is assessing the gross or microscopic response in the tissue sample resected at the time of surgery.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	22 of 123 (17.9%)	41 of 123 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20670921Yardley DA, Zubkus J, Daniel B, Inhorn R, Lane CM, Vazquez ER, Naot Y, Burris HA 3rd, Hainsworth JD. A phase II trial of dose-dense neoadjuvant gemcitabine, epirubicin, and albumin-bound paclitaxel with pegfilgrastim in the treatment of patients with locally advanced breast cancer. Clin Breast Cancer. 2010 Oct 1;10(5):367-72. doi: 10.3816/CBC.2010.n.048.

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RecruitingPhase 2
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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
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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.

Denise A. Yardley, MD principal investigator

SCRI Development Innovations, LLC

13 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 Gemcitabine, Epirubicin and Albumin-bound Paclitaxel in people with Breast Cancer, run by SCRI Development Innovations, LLC at 13 sites 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 10 inclusion and 7 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 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 13 sites 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 30 Nov 2012). 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?

Pathologic Complete Response (time frame: 18 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 NCT00193206, 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 23 Nov 2021.