Breast CancerPhase 2NCT00255788
Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer
A Phase 2 study testing everolimus in people with Breast Cancer, run by NCIC Clinical Trials Group at 5 sites in Canada.
Trial summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to see how well they work in treating patients with recurrent or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 5 sitesCanada
- Study dates
- 10 May 2005to 18 Jan 2011
- 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 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Metastatic or recurrent disease
- Considered incurable
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Two primary breast cancers allowed
- Paraffin-embedded primary or metastatic tumor sample available
- No known brain metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Sex
- Male or female
Menopausal status
- Not specified
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active uncontrolled infection
- No upper gastrointestinal condition or other condition that would preclude ability to take oral medication
- No other serious medical condition that would preclude study participation
- No psychiatric illness or neurologic disorder that would preclude study compliance
- No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder
PRIOR CONCURRENT THERAPY:
Chemotherapy
- At least 4 weeks since prior chemotherapy
- Prior adjuvant chemotherapy allowed
- No more than 1 prior chemotherapy regimen for metastatic or recurrent disease
Endocrine therapy
- At least 5 days since prior hormonal therapy
Radiotherapy
- At least 4 weeks since prior radiotherapy except for low-dose, limited-fraction, palliative, nonmyelosuppressive radiotherapy, defined as radiotherapy to < 20% of functioning bone marrow
- If prior radiotherapy was to sole site of disease, must have subsequent documented disease progression at that site
Surgery
- At least 3 weeks since prior major surgery
Other
- Concurrent prophylactic bisphosphonates allowed, if started prior to study entry
- No concurrent potent inhibitors of cytochrome 3A4, such as erythromycin, diltiazem, or ketoconazole and similar antifungals
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- No concurrent grapefruit juice
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Fraser Valley Cancer Centre at British Columbia Cancer Agency
Surrey, British Columbia, V3V 1Z2
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer
RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to see how well they work in treating patients with recurrent or metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of 2 different treatment schedules of everolimus, in terms of clinical/radiological response and early progression, in patients with recurrent or metastatic breast cancer.
Secondary
- Determine the time to progression and response duration in patients treated with these regimens.
- Determine the toxic effects of these regimens in these patients.
- Correlate molecular markers of mTOR activity in tumor tissue with objective tumor response in patients treated with these regimens.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to presence of visceral metastases (yes vs no) and prior chemotherapy regimens for recurrent disease (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral everolimus once daily on days 1-28.
- Arm II: Patients receive oral everolimus on days 1, 8, 15, and 22. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then periodically until disease progression.
PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- everolimus
- Keywords
- recurrent breast cancer, stage IV breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Everolimus - 28 days q 4 wk Receives: Drug: everolimus |
| Arm B | Active comparator | Everolimus - days 1, 8, 15 and 22 q 4wks Receives: Drug: everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Secondary outcomes (5)
Adverse event rates
Time to progression by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Response duration by evaluation 4 weeks after response and then every 8 weeks
Correlative assessment of response with molecular markers of mTor activity on archival tissue
Optional correlative assessment of response with molecular markers of mTor activity on fresh tissue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study start10 May 2005
- Primary completion22 Jul 2008
- Study completion18 Jan 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Susan Ellard, MD, Study chair, British Columbia Cancer Agency - Centre for the Southern InteriorKaren A. Gelmon, MD, Study chair, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255788
- Sponsor's protocol ID
- I163
- Other IDs
- CAN-NCIC-IND163, NOVARTIS-CAN-NCIC-IND163, CDR0000450849
- Status last verified
- Apr 2020
- First submitted
- 18 Nov 2005
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ellard SL, Clemons M, Gelmon KA, Norris B, Kennecke H, Chia S, Pritchard K, Eisen A, Vandenberg T, Taylor M, Sauerbrei E, Mishaeli M, Huntsman D, Walsh W, Olivo M, McIntosh L, Seymour L. Randomized phase II study comparing two schedules of everolimus in patients with recurrent/metastatic breast cancer: NCIC Clinical Trials Group IND.163. J Clin Oncol. 2009 Sep 20;27(27):4536-41. doi: 10.1200/JCO.2008.21.3033. Epub 2009 Aug 17.
PubMed 19687332
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00255788
- Acronym / sponsor ID
- I163
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IV breast cancer, male breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 10 May 2005 (actual)
- Primary completion
- 22 Jul 2008 (actual)
- Study completion
- 18 Jan 2011 (actual)
- First posted
- 21 Nov 2005 (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.
RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to see how well they work in treating patients with recurrent or metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of 2 different treatment schedules of everolimus, in terms of clinical/radiological response and early progression, in patients with recurrent or metastatic breast cancer.
Secondary
- Determine the time to progression and response duration in patients treated with these regimens.
- Determine the toxic effects of these regimens in these patients.
- Correlate molecular markers of mTOR activity in tumor tissue with objective tumor response in patients treated with these regimens.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to presence of visceral metastases (yes vs no) and prior chemotherapy regimens for recurrent disease (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral everolimus once daily on days 1-28.
- Arm II: Patients receive oral everolimus on days 1, 8, 15, and 22. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then periodically until disease progression.
PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: everolimusEverolimus - 28 days q 4 wk |
| Arm B | Active comparator | Drug: everolimusEverolimus - days 1, 8, 15 and 22 q 4wks |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| everolimus | Drug | Arm A, Arm B |
Primary outcome
Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
5 secondary outcomes
Adverse event rates
Time to progression by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Response duration by evaluation 4 weeks after response and then every 8 weeks
Correlative assessment of response with molecular markers of mTor activity on archival tissue
Optional correlative assessment of response with molecular markers of mTor activity on fresh tissue
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 4 Aug 2023.
- Results publication: PubMed 19687332Ellard SL, Clemons M, Gelmon KA, Norris B, Kennecke H, Chia S, Pritchard K, Eisen A, Vandenberg T, Taylor M, Sauerbrei E, Mishaeli M, Huntsman D, Walsh W, Olivo M, McIntosh L, Seymour L. Randomized phase II study comparing two schedules of everolimus in patients with recurrent/metastatic breast cancer: NCIC Clinical Trials Group IND.163. J Clin Oncol. 2009 Sep 20;27(27):4536-41. doi: 10.1200/JCO.2008.21.3033. Epub 2009 Aug 17.
- Individual participant dataSharing planned: No
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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.
Susan Ellard, MD study chair
British Columbia Cancer Agency - Centre for the Southern Interior
Karen A. Gelmon, MD study chair
British Columbia Cancer Agency
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 everolimus in people with Breast Cancer, run by NCIC Clinical Trials Group at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Aug 2023. 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 Canada. 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?
Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks. The study lists 2 primary outcomes in all. 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 NCT00255788, 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 4 Aug 2023.