Breast Cancer Nos Metastatic RecurrentPhase 3NCT01644890
A Phase III Study of NK105 in Patients With Breast Cancer
A Phase 3 study testing NK105 and Paclitaxel in people with Breast Cancer Nos Metastatic Recurrent, run by Nippon Kayaku Co., Ltd. at 1 site in Japan.
Trial summary
To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer. Read more about this study
- Who is it for?
- Ages 20 to 74 years, women only
- Conditions the study is for
- Breast Cancer Nos Metastatic Recurrent
- What is being tested?
- NK105 and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2012to Jan 2017
- Phase
- Phase 3
- 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 20 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent of the patient signed by herself.
- Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.
- Aged 20 to 74 at the time of informed consent.
Who cannot join
- Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.
Read the detailed description
This study is a randomized, open-label, multi-national phase III study.
- Conditions
- Breast Cancer Nos Metastatic Recurrent
- Being tested
- NK105, Paclitaxel
- Keywords
- NK105, Paclitaxel, Breast cancer, Micelle
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK105Drug
IV, Weekly
PaclitaxelDrug
IV, Weekly
| Study group | Role | What they receive |
|---|---|---|
| NK105 | Experimental | Not described Receives: Drug: NK105 |
| Paclitaxel | Active comparator | Not described Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1.
Assessment period was from the day of randomisation until the first observation of lesion progression or death
Measured: Baseline, every 6 weeks of study treatment period, and end of study,
Secondary outcomes (2)
Overall Survival
OS is defined as the period from the day of randomization until the day of death from any cause.
Assessment period was from the day of randomisation until the first observation of lesion progression or death
Measured: Baseline, every 6 weeks of study treatment period, and end of study.
Overall Response Rate
ORR is the proportion of patients who are assessed as complete response or partial response as the best overall response among evaluable patients, according to RECIST Ver.1.1.
Assessment period was from the day of randomisation until the first observation of lesion progression or death
Measured: Baseline, every 6 weeks of study treatment period, and end of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2016
- Study completionJan 2017
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 Cancer Nos Metastatic RecurrentStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nippon Kayaku Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time), Study director, Nippon Kayaku Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644890
- Sponsor's protocol ID
- A3105301
- Status last verified
- Feb 2016
- First submitted
- 17 Jul 2012
- Last updated
- 29 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fujiwara Y, Mukai H, Saeki T, Ro J, Lin YC, Nagai SE, Lee KS, Watanabe J, Ohtani S, Kim SB, Kuroi K, Tsugawa K, Tokuda Y, Iwata H, Park YH, Yang Y, Nambu Y. A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients. Br J Cancer. 2019 Mar;120(5):475-480. doi: 10.1038/s41416-019-0391-z. Epub 2019 Feb 12.
PubMed 30745582
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT01644890
- Acronym / sponsor ID
- A3105301
- Conditions
- Breast Cancer Nos Metastatic Recurrent
- Keywords
- NK105, Paclitaxel, Breast cancer, Micelle
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Nippon Kayaku Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Posted 29 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.
Detailed description
This study is a randomized, open-label, multi-national phase III study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NK105 | Experimental | Drug: NK105 |
| Paclitaxel | Active comparator | Drug: Paclitaxel |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent of the patient signed by herself.
- Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.
- Aged 20 to 74 at the time of informed consent.
Key exclusion criteria (1 listed)
- Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.
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 |
|---|---|---|
| NK105IV, Weekly | Drug | NK105 |
| PaclitaxelIV, Weekly | Drug | Paclitaxel |
Primary outcome
Progression Free Survival
Time frame: Baseline, every 6 weeks of study treatment period, and end of study,
PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1. Assessment period was from the day of randomisation until the first observation of lesion progression or death
2 secondary outcomes
Overall Survival
Time frame: Baseline, every 6 weeks of study treatment period, and end of study.
Overall Response Rate
Time frame: Baseline, every 6 weeks of study treatment period, and end of study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30745582Fujiwara Y, Mukai H, Saeki T, Ro J, Lin YC, Nagai SE, Lee KS, Watanabe J, Ohtani S, Kim SB, Kuroi K, Tsugawa K, Tokuda Y, Iwata H, Park YH, Yang Y, Nambu Y. A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients. Br J Cancer. 2019 Mar;120(5):475-480. doi: 10.1038/s41416-019-0391-z. Epub 2019 Feb 12.
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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.
Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time) study director
Nippon Kayaku Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NK105 and Paclitaxel in people with Breast Cancer Nos Metastatic Recurrent, run by Nippon Kayaku Co., Ltd. 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 3 inclusion and 1 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 29 Jul 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 29 Jul 2019). 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?
Progression Free Survival (time frame: Baseline, every 6 weeks of study treatment period, and end of study,). 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 NCT01644890, 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 29 Jul 2019.