Breast NeoplasmPhase 2NCT00270894
Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
A Phase 2 study testing epirubicin, cyclophosphamide and docetaxel in people with Breast Neoplasm, run by Accelerated Community Oncology Research Network at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients: trastuzumab (Herceptin) epirubicin (Ellence) cyclophosphamide (Cytoxan) docetaxel (Taxotere) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- epirubicin, cyclophosphamide and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2005to Aug 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant females =/> 18 years of age
- Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative
- Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status
- Normal cardiac function and adequate hematologic function
- Human epidermal growth factor receptor 2 protein (HER2) positive
- No evidence of metastatic disease
- ECOG Performance Status 0 - 1
- Women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment
Who cannot join
- Treated with other investigational drugs within 30 days
- Uncontrolled intercurrent disease or active infection
- Known sensitivity to e. coli-derived proteins or polysorbate 80
- Psychiatric illness or social situation that would limit study compliance
- Pre-existing peripheral neuropathy > Grade 1
- Cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast
Show all 9Show fewer
- Bilateral synchronous breast cancer
- Inflammatory breast cancer
- Women who are pregnant or breast feeding
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Augusta Oncology Associates
Augusta, Georgia, 30901
Hematology Oncology Centers of the Northern Rockies, PC
Billings, Montana, 59101
Arena Oncology Associates
Great Neck, New York, 11021
Cental Georgia Cancer Care
Macon, Georgia, 31201
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060
The West Clinic
Memphis, Tennessee, 38120
Advanced Medical Specialties
Miami, Florida, 33176
About this study
Official title: Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients:
- trastuzumab (Herceptin)
- epirubicin (Ellence)
- cyclophosphamide (Cytoxan)
- docetaxel (Taxotere)
Read the detailed description
This is an investigator-initiated, Phase II, non-randomized, single-arm, prospective treatment study. The study will consist of neoadjuvant treatment period (weeks 1 to 20), surgical evaluation period (weeks 20 to 24), and a post-surgical/follow-up period (approximately 3 years). Subjects will be treated on an outpatient basis.
Neoadjuvant therapy will consist of epirubicin + cyclophosphamide given every 2 weeks for four cycles followed by a three week break. Subjects will then receive docetaxel every two weeks for four cycles + trastuzumab (one loading dose) then maintenance dose every 2 weeks for 4 treatments.
- Conditions
- Breast Neoplasm
- Being tested
- epirubicin, cyclophosphamide, docetaxel, trastuzumab
- Keywords
- neoadjuvant chemotherapy, HER2 positive breast cancer, stage II - III 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.
epirubicinDrug
Also called Ellence®
epirubicin (100 mg/m^2) every 2 weeks for 4 cycles
cyclophosphamideDrug
Also called Cytoxan
cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles
docetaxelDrug
Also called Taxotere®
docetaxel (75 mg/m^2) every 2 weeks for 4 cycles
trastuzumabDrug
Also called Herceptin®
trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy | Experimental | Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments. Receives: Drug: epirubicin; Drug: cyclophosphamide; Drug: docetaxel; Drug: trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.
Measured: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)
Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities
Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE.
Measured: Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.
Secondary outcomes (5)
Pathologic Response
Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as >= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as < 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and < 25% increase in sum of diameters.
Measured: At completion of neoadjuvant treatment period, up to 24 weeks.
Clinical Response Prior to Surgery
Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as >= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as < 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and < 25% increase in sum of diameters.
Measured: Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.
Left Ventricular Ejection Fraction (LVEF)
LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up.
Measured: At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36
Progression-free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
Measured: PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.
Overall Survival (OS)
Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.
Measured: Measured from day 1 of treatment until time of death, assessed up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionAug 2011
- Study completionAug 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.
- Other trials for Breast NeoplasmStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accelerated Community Oncology Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Lee S Schwartzberg, MD, FACP, Study chair, Accelerated Community Oncology Research Network, Inc. (ACORN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270894
- Sponsor's protocol ID
- ACORN ALSSNBC0401
- Status last verified
- Mar 2012
- First submitted
- 28 Dec 2005
- Last updated
- 20 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00270894
- Acronym / sponsor ID
- ACORN ALSSNBC0401
- Conditions
- Breast Neoplasm
- Keywords
- neoadjuvant chemotherapy, HER2 positive breast cancer, stage II - III breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Accelerated Community Oncology Research NetworkUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Nov 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Dec 2005 (estimated)
- Results
- Posted 12 Mar 2012
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 effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients:
- trastuzumab (Herceptin)
- epirubicin (Ellence)
- cyclophosphamide (Cytoxan)
- docetaxel (Taxotere)
Detailed description
This is an investigator-initiated, Phase II, non-randomized, single-arm, prospective treatment study. The study will consist of neoadjuvant treatment period (weeks 1 to 20), surgical evaluation period (weeks 20 to 24), and a post-surgical/follow-up period (approximately 3 years). Subjects will be treated on an outpatient basis.
Neoadjuvant therapy will consist of epirubicin + cyclophosphamide given every 2 weeks for four cycles followed by a three week break. Subjects will then receive docetaxel every two weeks for four cycles + trastuzumab (one loading dose) then maintenance dose every 2 weeks for 4 treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy | Experimental | Drug: epirubicin, Drug: cyclophosphamide, Drug: docetaxel, Drug: trastuzumabNeoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Non-pregnant females =/> 18 years of age
- Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative
- Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status
- Normal cardiac function and adequate hematologic function
- Human epidermal growth factor receptor 2 protein (HER2) positive
Key exclusion criteria (9 listed)
- Treated with other investigational drugs within 30 days
- Uncontrolled intercurrent disease or active infection
- Known sensitivity to e. coli-derived proteins or polysorbate 80
- Psychiatric illness or social situation that would limit study compliance
- Pre-existing peripheral neuropathy > Grade 1
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 |
|---|---|---|
| epirubicinAlso: Ellence®epirubicin (100 mg/m^2) every 2 weeks for 4 cycles | Drug | Neoadjuvant therapy |
| cyclophosphamideAlso: Cytoxancyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles | Drug | Neoadjuvant therapy |
| docetaxelAlso: Taxotere®docetaxel (75 mg/m^2) every 2 weeks for 4 cycles | Drug | Neoadjuvant therapy |
| trastuzumabAlso: Herceptin®trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments | Drug | Neoadjuvant therapy |
Primary outcome
Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
Time frame: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)
Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.
Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities
Time frame: Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.
Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE.
5 secondary outcomes
Pathologic Response
Time frame: At completion of neoadjuvant treatment period, up to 24 weeks.
Clinical Response Prior to Surgery
Time frame: Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.
Left Ventricular Ejection Fraction (LVEF)
Time frame: At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36
Progression-free Survival (PFS)
Time frame: PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.
Overall Survival (OS)
Time frame: Measured from day 1 of treatment until time of death, assessed up to 48 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lee S Schwartzberg, MD, FACP study chair
Accelerated Community Oncology Research Network, Inc. (ACORN)
7 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 epirubicin, cyclophosphamide and docetaxel in people with Breast Neoplasm, run by Accelerated Community Oncology Research Network at 7 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 8 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: finished, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 12 Mar 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?
Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule (time frame: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)). The study lists 2 primary outcomes in all. 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 20 Mar 2012.