Breast CancerPhase 2NCT00193050
Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
A Phase 2 study testing Gemcitabine, Epirubicin and Docetaxel in people with Breast Cancer, run by SCRI Development Innovations, LLC.
Trial summary
Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. 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 Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to Mar 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:
- Adenocarcinoma of the breast confirmed by biopsy
- Female Patients >18 years of age
- Normal cardiac function
- Ability to perform activities of daily living with minimal assistance
- Chemotherapy naïve or have received prior chemotherapy > 5 years ago
Show all 10Show fewer
- Adequate bone marrow, liver and kidney function
- Be informed of the investigational nature of this study
- Sign an informed consent form
- Sentinel lymph node and/or axillary dissection prior to enrollment
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Life expectancy of < than 6 months
- History of significant heart disease
- Prior chemotherapy or hormonal therapy
- Concurrent Trastuzumab therapy
- History of significant psychiatric disorders
- 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.
About this study
Official title: Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients
Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.
Read the detailed description
Upon determination of eligibility, all patients will be receive:
Gemcitabine + Epirubicin + Docetaxel
- Conditions
- Breast Cancer
- Being tested
- Gemcitabine, Epirubicin, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Gemcitabine
EpirubicinDrug
Also called Ellence
Epirubicin
DocetaxelDrug
Also called Taxotere
Docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines. Receives: Drug: Gemcitabine; Drug: Epirubicin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR)
For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). 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 (2)
Time to Treatment Failure (TTF)
Time to Treatment Failure (TTF) is defined as the minimum of the time from first date of treatment to the either of the following dates:
- disease progression date (RECIST or clinical)
- death date
- treatment discontinuation
Measured: 69 months
Overall Survival (OS)
Number of participants that are alive at 48th months
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startNov 2001
- Primary completionMar 2008
- Study completionMar 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacia and Upjohn, Eli Lilly and Company, Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Denise A. Yardley, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193050
- Sponsor's protocol ID
- SCRI BRE 51
- Status last verified
- Oct 2021
- First submitted
- 12 Sep 2005
- Last updated
- 26 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yardley DA, Peacock NW, Dickson NR, White MB, Vazquez ER, Foust JT, Grapski R, Hendricks LK, Scott WL, Hainsworth JD. A phase II trial of neoadjuvant gemcitabine, epirubicin, and docetaxel as primary treatment of patients with locally advanced or inflammatory breast cancer. Clin Breast Cancer. 2010 Jun;10(3):217-23. doi: 10.3816/CBC.2010.n.029.
PubMed 20497920
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00193050
- Acronym / sponsor ID
- SCRI BRE 51
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Pharmacia and Upjohn, Eli Lilly and Company, Aventis Pharmaceuticals
- Study start
- Nov 2001
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 21 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.
Detailed description
Upon determination of eligibility, all patients will be receive:
Gemcitabine + Epirubicin + Docetaxel
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: DocetaxelIn the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines. |
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)
- Adenocarcinoma of the breast confirmed by biopsy
- Female Patients >18 years of age
- Normal cardiac function
- Ability to perform activities of daily living with minimal assistance
- Chemotherapy naïve or have received prior chemotherapy > 5 years ago
Key exclusion criteria (8 listed)
- Life expectancy of < than 6 months
- History of significant heart disease
- Prior chemotherapy or hormonal therapy
- Concurrent Trastuzumab therapy
- History of significant psychiatric disorders
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: GemzarGemcitabine | Drug | Intervention |
| EpirubicinAlso: EllenceEpirubicin | Drug | Intervention |
| DocetaxelAlso: TaxotereDocetaxel | Drug | Intervention |
Primary outcome
Pathologic Complete Response (pCR)
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). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
2 secondary outcomes
Time to Treatment Failure (TTF)
Time frame: 69 months
Overall Survival (OS)
Time frame: 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20497920Yardley DA, Peacock NW, Dickson NR, White MB, Vazquez ER, Foust JT, Grapski R, Hendricks LK, Scott WL, Hainsworth JD. A phase II trial of neoadjuvant gemcitabine, epirubicin, and docetaxel as primary treatment of patients with locally advanced or inflammatory breast cancer. Clin Breast Cancer. 2010 Jun;10(3):217-23. doi: 10.3816/CBC.2010.n.029.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Epirubicin and Docetaxel in people with Breast Cancer, run by SCRI Development Innovations, LLC.
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 8 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 26 Oct 2021. 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.
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 21 Sep 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 (pCR) (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 NCT00193050, 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 26 Oct 2021.