Breast CancerPhase 3NCT01402193
Study of Arimidex and Radiotherapy Sequencing
A Phase 3 study testing Pre-radiotherapy commencement of Arimidex, Post radiotherapy commencement of Arimidex and Radiotherapy in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pre-radiotherapy commencement of Arimidex, Post radiotherapy commencement of Arimidex and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Jul 2015
- Phase
- Phase 3
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Pathological confirmation of breast cancer
- ER(+) and/or PR(+).
- Post-menopausal woman
- Age≤70 years old
- Breast conservative surgery with axillary dissection or staging by either sentinel nodes biopsy or axillary sampling
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- Post-mastectomy patients with T1-T2 and N1-N3, or T3-T4 with any N Negative surgical margins
- Karnofsky≥70
- Laboratory criteria:
- PLT≥100*109/L
- WBC≥4000/mm3
- HGB≥10g/dl
- ALT and AST<2*ULN
- No presence of metastatic disease
- No other malignant tumour
Who cannot join
- Presence of metastatic disease.
- T1, T2, N0 with mastectomy
- Non-infiltrative breast carcinoma underwent mastectomy
- Other malignant tumor (concurrent or previous).
- Positive surgical margins.
- Patients with demonstrated hypersensitivity to Arimidex or any excipient.
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- Patients with severe renal impairment (creatinine clearance less than 20 ml/min).
- Patients with moderate or severe hepatic disease.
- Oestrogen-containing therapies should not be co-administered with Arimidex as they would negate its pharmacological action.
- Not able or willing to sign informed consent
- Autoimmune diseases including scleroderma, systemic lupus erythematosus and so on
Trial locations and contacts
1 site in 1 country.
Jiayi Chen, MD contact
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Jiayi Chen, MD, 862164175590 ext. 6602
Jiayi Chen, MD
About this study
Official title: A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Radiotherapy With Concomitant or Sequential Arimidex in Postmenopausal Women With Breast Cancer
The purpose of this study is to compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.
- Conditions
- Breast Cancer
- Being tested
- Pre-radiotherapy commencement of Arimidex, Post radiotherapy commencement of Arimidex, Radiotherapy
- Keywords
- Breast Cancer, Timing of Radiotherapy, TGF-beta1
- Medical subject headings
- Breast Neoplasms, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-radiotherapy commencement of ArimidexDrug
Also called Anastrozole
Arimidex:1mg P.O. daily will be prescribed for 8 weeks in post-mastectomy patients and 9 weeks in BCT patients within the study period. Arimidex starts 3 weeks before adjuvant radiotherapy and throughout the course of radiotherapy.Total duration of adjuvant hormonotherapy is prescribed by the investigators at the completion of study, 5 years in principle.
Post radiotherapy commencement of ArimidexDrug
Also called Anastrozole
Arimidex：1mg P.O. daily will be prescribed at 2 weeks after the end of radiotherapy.Total duration of adjuvant hormonotherapy is prescribed by the investigators at the completion of study, 5 years in principle.
RadiotherapyRadiation
Also called RT, Radiation Therapy
Radiotherapy is delivered to the whole breast/chest wall +/- regional lymph nodes to a total dose of 50Gy/25 fractions/5weeks, an additional tumor bed boost of 10Gy/5 fractions/1week is delivered to patients with breast conservative surgery
RadiotherapyRadiation
Also called RT, Radiation Therapy
Radiotherapy is delivered to the whole breast/chest wall +/- regional lymph nodes to a total dose of 50Gy/25 fractions/5weeks, an additional tumor bed boost of 10Gy/5 fractions/1week is delivered to patients with breast conservative surgery
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Active comparator | Investigational treatment: Arimidex commenced before and continued during radiotherapy.
Interventions:
Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy Receives: Drug: Pre-radiotherapy commencement of Arimidex; Radiation: Radiotherapy |
| Control Arm | Active comparator | Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy
Interventions:
Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex Receives: Drug: Post radiotherapy commencement of Arimidex; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of TGF-β1
To compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.
Measured: First analysis will occur 1 year after first subject enrolled
Secondary outcomes (6)
Acute skin reaction
Acute skin reaction occurrence rate defined by the occurrence of grade II or above acute skin reaction in patients with concurrent or sequential arimidex with radiotherapy.
Measured: First analysis will occur 1 year after first subject enrolled
Other serum inflammatory cytokine
Pre-and post-radiotherapy other serum inflammatory cytokine
Measured: First analysis will occur 1 year after first subject enrolled
Cosmetic outcomes
Cosmetic outcomes in patients receiving breast conservative therapy treated by both arms.
Measured: First analysis will occur 1 year after first subject enrolled
Lung toxicity
Occurrence of grade II or higher radiation-induced lung toxicity.
Measured: First analysis will occur 1 year after first subject enrolled
Local-regional recurrence
Local-regional recurrence within two arms.
Measured: First analysis will occur 1 year after first subject enrolled
Correlation between TGF-β1 Change and Clinical Outcomes
The correlation between TGF-β1 change and clinical outcomes will be explored.
Measured: First analysis will occur 1 year after first subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Jiayi Chen, Fudan University
- Investigators
- Jiayi Chen, MD, Principal investigator, The Department of Radiation Oncology, Fudan University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402193
- Sponsor's protocol ID
- BR-RT-002
- Status last verified
- Jun 2014
- First submitted
- 25 Jul 2011
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Radiotherapy With Concomitant or Sequential Arimidex in Postmenopausal Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01402193
- Acronym / sponsor ID
- BR-RT-002
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Timing of Radiotherapy, TGF-beta1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 26 Jul 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 compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Active comparator | Drug: Pre-radiotherapy commencement of Arimidex, Radiation: RadiotherapyInvestigational treatment: Arimidex commenced before and continued during radiotherapy. Interventions: Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy |
| Control Arm | Active comparator | Drug: Post radiotherapy commencement of Arimidex, Radiation: RadiotherapyStandard Treatment: Arimidex delayed until 2 weeks after radiotherapy Interventions: Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provision of informed consent
- Pathological confirmation of breast cancer
- ER(+) and/or PR(+).
- Post-menopausal woman
- Age≤70 years old
Key exclusion criteria (11 listed)
- Presence of metastatic disease.
- T1, T2, N0 with mastectomy
- Non-infiltrative breast carcinoma underwent mastectomy
- Other malignant tumor (concurrent or previous).
- Positive surgical margins.
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 |
|---|---|---|
| Pre-radiotherapy commencement of ArimidexAlso: AnastrozoleArimidex:1mg P.O. daily will be prescribed for 8 weeks in post-mastectomy patients and 9 weeks in BCT patients within the study period. Arimidex starts 3 weeks before adjuvant radiotherapy and throughout the course of radiotherapy.Total duration of adjuvant hormonotherapy is prescribed by the investigators at the completion of study, 5 years in principle. | Drug | Study Arm |
| Post radiotherapy commencement of ArimidexAlso: AnastrozoleArimidex：1mg P.O. daily will be prescribed at 2 weeks after the end of radiotherapy.Total duration of adjuvant hormonotherapy is prescribed by the investigators at the completion of study, 5 years in principle. | Drug | Control Arm |
| RadiotherapyAlso: RT, Radiation TherapyRadiotherapy is delivered to the whole breast/chest wall +/- regional lymph nodes to a total dose of 50Gy/25 fractions/5weeks, an additional tumor bed boost of 10Gy/5 fractions/1week is delivered to patients with breast conservative surgery | Radiation | Study Arm |
| RadiotherapyAlso: RT, Radiation TherapyRadiotherapy is delivered to the whole breast/chest wall +/- regional lymph nodes to a total dose of 50Gy/25 fractions/5weeks, an additional tumor bed boost of 10Gy/5 fractions/1week is delivered to patients with breast conservative surgery | Radiation | Control Arm |
Primary outcome
Level of TGF-β1
Time frame: First analysis will occur 1 year after first subject enrolled
To compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.
6 secondary outcomes
Acute skin reaction
Time frame: First analysis will occur 1 year after first subject enrolled
Other serum inflammatory cytokine
Time frame: First analysis will occur 1 year after first subject enrolled
Cosmetic outcomes
Time frame: First analysis will occur 1 year after first subject enrolled
Lung toxicity
Time frame: First analysis will occur 1 year after first subject enrolled
Local-regional recurrence
Time frame: First analysis will occur 1 year after first subject enrolled
Correlation between TGF-β1 Change and Clinical Outcomes
Time frame: First analysis will occur 1 year after first subject enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
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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.
Jiayi Chen, MD contact
Jiayi Chen, MD principal investigator
The Department of Radiation Oncology, Fudan University Cancer Hospital
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 Pre-radiotherapy commencement of Arimidex, Post radiotherapy commencement of Arimidex and Radiotherapy in people with Breast Cancer, run by Fudan University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 25 Jun 2014. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayi Chen, MD (862164175590 ext. 6602), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of TGF-β1 (time frame: First analysis will occur 1 year after first subject enrolled). 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 25 Jun 2014.