Breast CancerPhase 2NCT00617942
Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer
A Phase 2 study testing Cohort 1 neo-adjuvant, Cohort 2 neo-adjuvant and Cohort 1 adjuvant in people with Breast Cancer, run by William Sikov MD at 5 sites in United States.
Trial summary
Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer 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?
- Cohort 1 neo-adjuvant, Cohort 2 neo-adjuvant and Cohort 1 adjuvant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2008to Dec 2015
- 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
- Histologically documented adenocarcinoma of the breast
- ANC > 1000 cells
- Female; age > 18; Zubrod PS 0-1
- Platelets > 100,000
- Stage IIA-IIIB disease
- Total bilirubin < or = ULN
Show all 15Show fewer
- No evidence of metastatic disease Not pregnant or lactating
- No prior systemic therapy for this breast cancer
- Serum Creatinine < 1.5 mg/dl or Creat Cl > 30 ml/min
- Serum ALT < 2.5 x ULN
- ER, PR and HER2 status required
- LVEF (MUGA/echo)WNL
- No baseline > 2 neuropathy
- Hemoglobin > 9.0 gm/dl
- HER2+, defined by IHC 3+ or FISH ratio > 2.0
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
City of Hope
Duarte, California, 91010
Yale Smilow Cancer Center
New Haven, Connecticut, 06437
Women and Infants Hospital
Providence, Rhode Island, 02903
Roger Williams Medical Center
Providence, Rhode Island, 02908
Rhode Island and The Miriam Hospital
Providence, Rhode Island, 02912
About this study
Official title: BrUOG-BR-211B q3week Carboplatin With Weekly Abraxane and Trastuzumab As Neoadjuvant Therapy in Resectable and Unresectable HER2+ (Stage IIa-IIIb) Breast Cancer
Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer
Read the detailed description
Our goal is to develop an induction chemotherapy regimen that will have a pCR rate above 50% in HER2+ patients without exposing patients to the toxicity of an anthracycline-based regimen. A minimum of 60 evaluable patients will be accrued to the study. We are assuming an observed pCR (or near pCR) rate of 70%. Assuming no more than 10% of patients will be inevaluable for the primary endpoint (pCR), we will have at least 54 evaluable patients. With this number, we will have 90% power, with a 1-sided alpha error of 0.05, to demonstrate a pCR rate exceeding 50% for our novel regimen.
- Conditions
- Breast Cancer
- Being tested
- Cohort 1 neo-adjuvant, Cohort 2 neo-adjuvant, Cohort 1 adjuvant, Cohort 2 adjuvant
- Keywords
- 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.
Cohort 1 neo-adjuvantDrug
Also called Abraxane (nab-paclitaxel), Herceptin (trastuzumab) and carboplatin
Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14
Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
Cohort 2 neo-adjuvantDrug
Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
Cohort 1 adjuvantDrug
Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
Cohort 2 adjuvantDrug
Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
| Study group | Role | What they receive |
|---|---|---|
| Neo-adjuvant cohort 1 | Experimental | Not described Receives: Drug: Cohort 1 neo-adjuvant |
| Neo-adjuvant cohort 2 | Experimental | Not described Receives: Drug: Cohort 2 neo-adjuvant |
| Adjuvant cohort 1 | Experimental | Not described Receives: Drug: Cohort 1 adjuvant |
| Adjuvant cohort 2 | Experimental | Not described Receives: Drug: Cohort 2 adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;
These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.
Measured: 1 year
Secondary outcomes (1)
Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity
Please note that these events represent toxicities that were experienced during treatment, but that does not mean that all toxicities were indeed deemed related to study treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2012
- Study completionDec 2015
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Sikov MD
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor-investigator, William Sikov MD, Brown University
- Investigators
- William Sikov, MD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617942
- Sponsor's protocol ID
- BrUOG-BR-211B
- Status last verified
- May 2020
- First submitted
- 6 Feb 2008
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cheng H, Bai Y, Sikov W, Sinclair N, Bossuyt V, Abu-Khalaf MM, Harris LN, Rimm DL. Quantitative measurements of HER2 and phospho-HER2 expression: correlation with pathologic response to neoadjuvant chemotherapy and trastuzumab. BMC Cancer. 2014 May 8;14:326. doi: 10.1186/1471-2407-14-326.
PubMed 24885187
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrUOG-BR-211B q3week Carboplatin With Weekly Abraxane and Trastuzumab As Neoadjuvant Therapy in Resectable and Unresectable HER2+ (Stage IIa-IIIb) Breast Cancer
- ClinicalTrials.gov ID
- NCT00617942
- Acronym / sponsor ID
- BrUOG-BR-211B
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- William Sikov MDUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- Feb 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Posted 22 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer
Detailed description
Our goal is to develop an induction chemotherapy regimen that will have a pCR rate above 50% in HER2+ patients without exposing patients to the toxicity of an anthracycline-based regimen. A minimum of 60 evaluable patients will be accrued to the study. We are assuming an observed pCR (or near pCR) rate of 70%. Assuming no more than 10% of patients will be inevaluable for the primary endpoint (pCR), we will have at least 54 evaluable patients. With this number, we will have 90% power, with a 1-sided alpha error of 0.05, to demonstrate a pCR rate exceeding 50% for our novel regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neo-adjuvant cohort 1 | Experimental | Drug: Cohort 1 neo-adjuvant |
| Neo-adjuvant cohort 2 | Experimental | Drug: Cohort 2 neo-adjuvant |
| Adjuvant cohort 1 | Experimental | Drug: Cohort 1 adjuvant |
| Adjuvant cohort 2 | Experimental | Drug: Cohort 2 adjuvant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically documented adenocarcinoma of the breast
- ANC > 1000 cells
- Female; age > 18; Zubrod PS 0-1
- Platelets > 100,000
- Stage IIA-IIIB disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cohort 1 neo-adjuvantAlso: Abraxane (nab-paclitaxel), Herceptin (trastuzumab) and carboplatinCohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14 Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16 | Drug | Neo-adjuvant cohort 1 |
| Cohort 2 neo-adjuvantCohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16 | Drug | Neo-adjuvant cohort 2 |
| Cohort 1 adjuvantTrastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians | Drug | Adjuvant cohort 1 |
| Cohort 2 adjuvantTrastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians | Drug | Adjuvant cohort 2 |
Primary outcome
Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;
Time frame: 1 year
These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.
1 secondary outcome
Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24885187Cheng H, Bai Y, Sikov W, Sinclair N, Bossuyt V, Abu-Khalaf MM, Harris LN, Rimm DL. Quantitative measurements of HER2 and phospho-HER2 expression: correlation with pathologic response to neoadjuvant chemotherapy and trastuzumab. BMC Cancer. 2014 May 8;14:326. doi: 10.1186/1471-2407-14-326.
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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.
William Sikov, MD principal investigator
Brown University
5 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 Cohort 1 neo-adjuvant, Cohort 2 neo-adjuvant and Cohort 1 adjuvant in people with Breast Cancer, run by William Sikov MD at 5 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 15 inclusion and 0 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 22 Aug 2017). 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?
Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC; (time frame: 1 year). 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 NCT00617942, 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 11 Jun 2020.