Breast CancerPhase 2NCT01432223
Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
A Phase 2 study testing Nab-paclitaxel in people with Breast Cancer and HER-2 Positive Breast Cancer, run by Osaka Medical College at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer, HER-2 Positive Breast Cancer, Effects of Chemotherapy
- What is being tested?
- Nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2011to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive breast cancer
- T1c-3 N0-2a
- Confirmed of hormonal receptor status
- HER2 positive confirmed by IHC 3+ or FISH+
- LVEF > 50% by echocardiogram or MUGA
- Adequate EKG
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- No prior treatment for breast cancer
- PS 0-1
- Required baseline laboratory data WBC > 4,000/mm3 and Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST and ALT < ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl
- Written informed consent
Who cannot join
- With history of hypersensitivity reaction for important drug in this study
- With history of invasive breast cancer
- Bilateral invasive breast cancer
- Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
- Positive for HBs antigen and with history of HVB
- With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
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- With severe edema
- With severe peripheral neuropathy
- With severe psychiatric disorder
- Pregnant or nursing women
- Cases who physician judged improper to entry this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.
Read the detailed description
Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated.
Anthracycline-based regimen (d1, q3w):
EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)
Nab-paclitaxel 260mg/m2 (d1, q3w)
Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.
- Being tested
- Nab-paclitaxel
- Keywords
- Trastuzumab, Neoadjuvant chemotherapy, Primary chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
Also called Abraxane
Nab-paclitaxel 260mg/m2 q3w
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel | Experimental | Nab-paclitaxel q3w 260mg/m2 Receives: Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pathological complete response rate
Measured: 1 year from last patient enrolled
Secondary outcomes (5)
Disease free survival
Measured: 5 years from the last patient enrolled
Overall response rate
Measured: After the protocol therapy
Pathological response rate
Measured: After the protocol therapy
Breast-conserving surgery rate
Measured: After the protocol therapy
Safety
Measured: Within the protocol thepapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satoru Tanaka, Osaka Medical College
- Investigators
- Mitsuhiko Iwamoto, MD, PhD, Principal investigator, Osaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432223
- Sponsor's protocol ID
- OMC-BC01
- Other IDs
- UMIN000006288
- Status last verified
- Apr 2015
- First submitted
- 8 Sep 2011
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tanaka S, Iwamoto M, Kimura K, Matsunami N, Morishima H, Yoshidome K, Nomura T, Morimoto T, Yamamoto D, Tsubota Y, Kobayashi T, Uchiyama K. Phase II Study of Neoadjuvant Anthracycline-Based Regimens Combined With Nanoparticle Albumin-Bound Paclitaxel and Trastuzumab for Human Epidermal Growth Factor Receptor 2-Positive Operable Breast Cancer. Clin Breast Cancer. 2015 Jun;15(3):191-6. doi: 10.1016/j.clbc.2014.12.003. Epub 2014 Dec 24.
PubMed 25579459
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01432223
- Acronym / sponsor ID
- OMC-BC01
- Keywords
- Trastuzumab, Neoadjuvant chemotherapy, Primary chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Osaka Medical CollegeUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Not posted in the source record
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 efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.
Detailed description
Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated.
Anthracycline-based regimen (d1, q3w):
EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)
Nab-paclitaxel 260mg/m2 (d1, q3w)
Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel | Experimental | Drug: Nab-paclitaxelNab-paclitaxel q3w 260mg/m2 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed invasive breast cancer
- T1c-3 N0-2a
- Confirmed of hormonal receptor status
- HER2 positive confirmed by IHC 3+ or FISH+
- LVEF > 50% by echocardiogram or MUGA
Key exclusion criteria (11 listed)
- With history of hypersensitivity reaction for important drug in this study
- With history of invasive breast cancer
- Bilateral invasive breast cancer
- Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
- Positive for HBs antigen and with history of HVB
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 |
|---|---|---|
| Nab-paclitaxelAlso: AbraxaneNab-paclitaxel 260mg/m2 q3w | Drug | Nab-paclitaxel |
Primary outcome
To evaluate the pathological complete response rate
Time frame: 1 year from last patient enrolled
5 secondary outcomes
Disease free survival
Time frame: 5 years from the last patient enrolled
Overall response rate
Time frame: After the protocol therapy
Pathological response rate
Time frame: After the protocol therapy
Breast-conserving surgery rate
Time frame: After the protocol therapy
Safety
Time frame: Within the protocol thepapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Results publication: PubMed 25579459Tanaka S, Iwamoto M, Kimura K, Matsunami N, Morishima H, Yoshidome K, Nomura T, Morimoto T, Yamamoto D, Tsubota Y, Kobayashi T, Uchiyama K. Phase II Study of Neoadjuvant Anthracycline-Based Regimens Combined With Nanoparticle Albumin-Bound Paclitaxel and Trastuzumab for Human Epidermal Growth Factor Receptor 2-Positive Operable Breast Cancer. Clin Breast Cancer. 2015 Jun;15(3):191-6. doi: 10.1016/j.clbc.2014.12.003. Epub 2014 Dec 24.
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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.
Mitsuhiko Iwamoto, MD, PhD principal investigator
Osaka Medical College
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 Nab-paclitaxel in people with Breast Cancer and HER-2 Positive Breast Cancer, run by Osaka Medical College at 1 site in Japan.
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 11 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 22 Apr 2015. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the pathological complete response rate (time frame: 1 year from last patient enrolled). 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 NCT01432223, 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 22 Apr 2015.