Breast CancerPhase 2NCT00796107

A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer

A Phase 2 study testing RG1507 and Letrozole in people with Breast Cancer, run by Hoffmann-La Roche at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: RG1507 and Letrozole
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 6 sitesUnited States
Study dates: 28 Jan 2009to 3 Mar 2010
Phase: Phase 2
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

postmenopausal female patients;
stage IV or locally advanced breast cancer;
measurable disease;
letrozole failure (Part 2);
Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Who cannot join

previous chemotherapy for metastatic breast cancer;
concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug;
history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix;
concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Atlanta, Georgia, 30322
Study site
Birmingham, Alabama, 35294-3300
Study site
Houston, Texas, 77030
Study site
Miami, Florida, 33136
Study site
St Louis, Missouri, 63110
Study site
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.

Conditions: Breast Cancer
Being tested: RG1507, Letrozole
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RG1507Drug
R1507 was administered at a dose 16 mg/kg every 3 weeks.
LetrozoleDrug
Letrozole was administered orally at a dose 2.5 mg daily.

Study groups in NCT00796107
Study group	Role	What they receive
R1507 in Combination With Letrozole	Experimental	Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment. Receives: Drug: RG1507; Drug: Letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Tumor Response (Part 2)
Measured: Up to 14 months

Secondary outcomes (3)

Pharmacokinetics (PK) Profile (Part 2)
Measured: Up to 14 months
Progression-free Survival (Part 2)
Measured: Up to 14 months
Number of Participants With Adverse Events (Part 2)
Measured: Up to 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 20093 Mar 2010

First posted24 Nov 2008 (estimated)
Study start28 Jan 2009
Primary completion3 Mar 2010
Study completion3 Mar 2010

Why it stopped: Due to the discontinuation of compound development, this study has been terminated.

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.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00796107
Sponsor's protocol ID: NO21161
Status last verified: Oct 2020
First submitted: 21 Nov 2008
Last updated: 13 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.
ClinicalTrials.gov ID: NCT00796107
Acronym / sponsor ID: NO21161
Conditions: Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the discontinuation of compound development, this study has been terminated.
Enrolment: 6 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 28 Jan 2009 (actual)
Primary completion: 3 Mar 2010 (actual)
Study completion: 3 Mar 2010 (actual)
First posted: 24 Nov 2008 (estimated)
Results: Posted 13 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
R1507 in Combination With Letrozole	Experimental	Drug: RG1507, Drug: LetrozoleParticipants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

postmenopausal female patients;
stage IV or locally advanced breast cancer;
measurable disease;
letrozole failure (Part 2);
Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Key exclusion criteria (4 listed)

previous chemotherapy for metastatic breast cancer;
concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug;
history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix;
concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.

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
RG1507R1507 was administered at a dose 16 mg/kg every 3 weeks.	Drug	R1507 in Combination With Letrozole
LetrozoleLetrozole was administered orally at a dose 2.5 mg daily.	Drug	R1507 in Combination With Letrozole

Primary outcome

Objective Tumor Response (Part 2)
Time frame: Up to 14 months

3 secondary outcomes

Pharmacokinetics (PK) Profile (Part 2)
Time frame: Up to 14 months
Progression-free Survival (Part 2)
Time frame: Up to 14 months
Number of Participants With Adverse Events (Part 2)
Time frame: Up to 14 months

Results and safety

Results posted to the registry on 13 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
R1507 in Combination With Letrozole	6	0

Primary outcome: Objective Tumor Response (Part 2)

Time frame: Up to 14 months

Population analysed: Phase 2 of this study was not conducted.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 13 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
R1507 in Combination With Letrozole	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6

Limitations and caveats (from the sponsor): Phase 2 of this study was not conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Not yet recruitingObservational study
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Clinical Trials study director

Hoffmann-La Roche

6 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 RG1507 and Letrozole in people with Breast Cancer, run by Hoffmann-La Roche at 6 sites in United States.

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 5 inclusion and 4 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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?

Yes. Results are posted in the registry (first posted 13 Nov 2020). 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?

Objective Tumor Response (Part 2) (time frame: Up to 14 months). 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 NCT00796107.

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 13 Nov 2020.