Breast NeoplasmsPhase 2Neo-ACET BCNCT01262274
Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
A Phase 2 study testing Anastrozole and Anastrozole plus tegafur-uracil in people with Breast Neoplasms, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
The Aim of this study is to validate a treatment of anastrozole in combination with tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although pre-operative hormone therapy is a novel therapeutic approach, only hormone therapy has limitation in terms of efficacy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Anastrozole and Anastrozole plus tegafur-uracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2010to Apr 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically-confirmed diagnosis of invasive breast cancer
- Clinical stage T2, N0 or N1, M0 (TNM Classification)
- Patients must be postmenopausal
- Tumors are estrogen receptor (ER) positive and human epidermal growth factor receptor (HER2) negative
- ECOG Performance status (PS) 0 or 1
- Patients must be able to swallow tablets and capsules
Show all 9Show fewer
- Candidates for mastectomy or breast-conserving surgery
- Adequate bone marrow, liver and renal function
- Written informed consent was obtained from all patients before randomization.
Who cannot join
- Inoperable, bilateral or inflammatory breast cancer
- multiple carcinoma
- Personal history of invasive carcinoma
- Patients receive systemic therapy of corticosteroid
- Patients receive estrogen preparation or raloxifene
- Patients with other concurrent severe and/or uncontrolled medical disease
- Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
Osaka, Osaka, 565-0871
About this study
Official title: Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer
The Aim of this study is to validate a treatment of anastrozole in combination with tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although pre-operative hormone therapy is a novel therapeutic approach, only hormone therapy has limitation in terms of efficacy. Metronomic chemotherapy, which is the frequent administration of low-dose cytotoxic agents, is not only target tumor cells but also inhibiting angiogenesis. Because there was a report that efficacy of hormone therapy add to metronomic chemotherapy as pre-operative therapy, a randomized phase II trial of anastrozole (ANA) in combination with/without metronomic tegafur-uracil (UFT) as neo-adjuvant for postmenopausal breast cancer will be conducted.
- Conditions
- Breast Neoplasms
- Being tested
- Anastrozole, Anastrozole plus tegafur-uracil
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
ANA is given 1mg daily for 24 weeks.
Anastrozole plus tegafur-uracilDrug
ANA is given 1mg daily for 24 weeks. UFT is given by 270mg/m2 twice a day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ANA | Active comparator | Not described Receives: Drug: Anastrozole |
| ANA+UFT | Experimental | Not described Receives: Drug: Anastrozole plus tegafur-uracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (confirmed by calipers CT or MRI)
Measured: six months
Secondary outcomes (1)
Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor
Measured: seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2013
- Study completionApr 2014
Why it stopped: Due to an adverse event revelation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Department of breast and endocrine surgery graduate school of Medicine Osaka University
- Responsible party
- Sponsor
- Investigators
- Shinzaburo Noguchi, M.D., Ph.D., Principal investigator, Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262274
- Sponsor's protocol ID
- TRIBC1009
- Acronym
- Neo-ACET BC
- Status last verified
- May 2015
- First submitted
- 15 Dec 2010
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT01262274
- Acronym / sponsor ID
- Neo-ACET BC / TRIBC1009
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to an adverse event revelation.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Department of breast and endocrine surgery graduate school of Medicine Osaka University
- Study start
- Dec 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Dec 2010 (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 Aim of this study is to validate a treatment of anastrozole in combination with tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although pre-operative hormone therapy is a novel therapeutic approach, only hormone therapy has limitation in terms of efficacy. Metronomic chemotherapy, which is the frequent administration of low-dose cytotoxic agents, is not only target tumor cells but also inhibiting angiogenesis. Because there was a report that efficacy of hormone therapy add to metronomic chemotherapy as pre-operative therapy, a randomized phase II trial of anastrozole (ANA) in combination with/without metronomic tegafur-uracil (UFT) as neo-adjuvant for postmenopausal breast cancer will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANA | Active comparator | Drug: Anastrozole |
| ANA+UFT | Experimental | Drug: Anastrozole plus tegafur-uracil |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically-confirmed diagnosis of invasive breast cancer
- Clinical stage T2, N0 or N1, M0 (TNM Classification)
- Patients must be postmenopausal
- Tumors are estrogen receptor (ER) positive and human epidermal growth factor receptor (HER2) negative
- ECOG Performance status (PS) 0 or 1
Key exclusion criteria (7 listed)
- Inoperable, bilateral or inflammatory breast cancer
- multiple carcinoma
- Personal history of invasive carcinoma
- Patients receive systemic therapy of corticosteroid
- Patients receive estrogen preparation or raloxifene
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 |
|---|---|---|
| AnastrozoleANA is given 1mg daily for 24 weeks. | Drug | ANA |
| Anastrozole plus tegafur-uracilANA is given 1mg daily for 24 weeks. UFT is given by 270mg/m2 twice a day for 24 weeks. | Drug | ANA+UFT |
Primary outcome
Response Rate (confirmed by calipers CT or MRI)
Time frame: six months
1 secondary outcome
Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor
Time frame: seven months
Results and safety
The study was stopped early (reason given: Due to an adverse event revelation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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.
Shinzaburo Noguchi, M.D., Ph.D. principal investigator
Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
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 Anastrozole and Anastrozole plus tegafur-uracil in people with Breast Neoplasms, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan 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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 May 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 was stopped early (reason given: Due to an adverse event revelation.). Results are not available in the source record.
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?
Response Rate (confirmed by calipers CT or MRI) (time frame: six months). 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 21 May 2015.