Breast CancerPhase 2NCT00773695

A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer

A Phase 2 study testing Aromatase Inhibitor, Bevacizumab and Epirubicine in people with Breast Cancer, run by Hoffmann-La Roche at 3 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
What is being tested?: Aromatase Inhibitor, Bevacizumab and Epirubicine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 3 sitesNorway
Study dates: 7 Nov 2008to 9 Nov 2022
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed, HER2-negative, men or pre- or post-menopausal women with primary operable adenocarcinoma of the breast, greater than or equal to (>=) 2.5 centimeters (cm) in size
Eastern Cooperative Oncology Group (ECOG)/world health organization (WHO) performance status less than or equal to (</=) 2
Normal baseline cardiac function (Left Ventricular Ejection Fraction [LVEF])

Who cannot join

Stage IV (metastatic) disease
Previous treatment for localized breast cancer less than (<) 24 months from diagnosis of present breast cancer
Other previous or current cancer except for basal cell cancer or in situ cervical cancer
Current or recent use of aspirin (greater than [>] 325 milligrams per day)
Clinically significant cardiovascular disease

Trial locations and contacts

3 sites in 1 country.

Norway3 sites

The Norvegian Radium Hospital Montebello; Dept of Oncology
Oslo, 0379
Ullevael Sykehus; Dept of Oncology
Oslo, 0407
St. Olavs Hospital; Kreftavdelingen
Trondheim, 7000

Other trials in Norway

About this study

Official title: A Multicenter, Randomized, Phase II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadjuvant Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Reference to the Obtained Responses in Patients With Large Primary HER2 Negative Breast Cancers

This study will evaluate the effect of bevacizumab in combination with chemotherapy or endocrine therapy, as preoperative treatment, in participants with HER2 negative breast cancer. Participants will be randomized to receive either chemotherapy (FEC100: Epirubicine 100 milligrams per square meter [mg/m^2], 5-fluorouracil 600 mg/m^2, and cyclophosphamide 600 mg/m^2] for 12 weeks followed by taxane (paclitaxel/docetaxel) for 12 weeks or endocrine therapy (an aromatase inhibitor] daily for 24 weeks) with or without bevacizumab (15 milligrams per kilogram [mg/kg] as intravenous [IV] infusion every 3 weeks up 24 weeks).

Conditions: Breast Cancer
Being tested: Aromatase Inhibitor, Bevacizumab, Epirubicine, 5-Fluorouracil (5FU), Cyclophosphamide
Medical subject headings: Breast Neoplasms

What participants receive

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

Aromatase InhibitorDrug
Participants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.
BevacizumabDrug
Also called Avastin
Bevacizumab will be administered at a dose of 15 mg/kg as IV infusion every 3 weeks (or 10 mg/kg every other week in participants receiving weekly paclitaxel), for 24 weeks.
EpirubicineDrug
Participants will receive epirubicine at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
5-Fluorouracil (5FU)Drug
Participants will receive 5FU at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
CyclophosphamideDrug
Participants will receive cyclophosphamide at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
PaclitaxelDrug
Participants will receive paclitaxel at a dose of 80 mg/m^2 as IV infusion every week for 12 weeks.
DocetaxelDrug
Participants will receive docetaxel at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.

Study groups in NCT00773695
Study group	Role	What they receive
Chemotherapy	Active comparator	Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Receives: Drug: Epirubicine; Drug: 5-Fluorouracil (5FU); Drug: Cyclophosphamide; Drug: Paclitaxel; Drug: Docetaxel
Chemotherapy and Bevacizumab	Experimental	Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Participants will also receive concurrent treatment with bevacizumab every 3 weeks for 24 weeks. Receives: Drug: Bevacizumab; Drug: Epirubicine; Drug: 5-Fluorouracil (5FU); Drug: Cyclophosphamide; Drug: Paclitaxel; Drug: Docetaxel
Endocrine Therapy	Active comparator	Participants will receive aromatase inhibitor therapy at discretion of the investigator for a period of 24 weeks. Receives: Drug: Aromatase Inhibitor
Endocrine Therapy and Bevacizumab	Experimental	Participants will receive aromatase inhibitor therapy at discretion of the investigator and concurrent treatment with bevacizumab for a period of 24 weeks. Receives: Drug: Aromatase Inhibitor; Drug: Bevacizumab

What is being measured

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

Percentage of Participants With Messenger Ribonucleic Acid (mRNA) Markers of Pathological Complete Response, as Assessed by Magnetic Resonance Imaging (MRI)
Measured: Baseline up to end of study treatment (approximately 24 weeks)

Secondary outcomes (22)

Percentage of Participants With Objective Pathological Complete Response, as Assessed by Clinical Assessment
Measured: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Type of Surgery
Percentage of participants with different surgery types (for example, Mastectomy, Tumorectomy/Breast conserving therapy (BCT), and Tumorectomy followed by mastectomy) will be reported.
Measured: At Surgery (Between Weeks 24 and 25)
Percentage of Participants With Axillary Lymph Node Dissection Performed
Measured: At Surgery (Between Weeks 24 and 25)
Pathological Tumor Size, as Assessed by Histopathological Examination
Measured: At Surgery (Between Weeks 24 and 25)
Percentage of Participants With Presence of Tumor Cells Close to Resection Margin
Measured: At Surgery (Between Weeks 24 and 25)
Percentage of Participants With Tumor Deposit in Other Body Parts
Measured: At Surgery (Between Weeks 24 and 25)
Tumor Free Resection Margin
Measured: At Surgery (Between Weeks 24 and 25)
Pathological Tumor Size as Measure Using Caliper
Measured: Cycles 1 to 10 (cycle length=21 days), and Week 25
Pathological Tumor Size as Measure Using MRI
Measured: Baseline, Weeks 12 and 25
Pathological Tumor Size as Measure Using Mamography
Measured: Baseline, Weeks 12 and 25
Pathological Breast Tumor Size as Measure Using Ultrasound
Measured: Baseline, Weeks 12 and 25
Pathological Axilla Tumor Size as Measure Using Ultrasound
Measured: Baseline, Weeks 12 and 25
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Measured: Screening, Cycles 1 to 10 (cycle length=21 days), and Week 25
Percentage of Participants With Lymph Node Involvement
Measured: Cycles 1 to 10 (cycle length=21 days), and Week 25
Percentage of Participants With Objective Tumor Response, as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Weeks 12 and 25
Percentage of Participants With New Lesions
Measured: Weeks 12 and 25
Percentage of Participants With Molecular Changes in Protein Kinase Expression
Measured: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Molecular Changes in Messenger Ribonucleic Acid (mRNA)/microRNA(miRNA)
Measured: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Molecular Changes in Protein Expression
Measured: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Single Nucleotide Polymorphism (SNP) Profiles Predicting Treatment Response
Measured: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Disseminated Tumor Cells in Bone Marrow
Measured: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Circulating Tumor Cells in Peripheral Blood
Measured: Baseline up to end of study treatment (approximately 24 weeks)

Timeline

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

7 Nov 20089 Nov 2022

First posted16 Oct 2008 (estimated)
Study start7 Nov 2008
Primary completion9 Nov 2022
Study completion9 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00773695
Sponsor's protocol ID: ML21744
Status last verified: Jan 2023
First submitted: 15 Oct 2008
Last updated: 9 Jan 2023
Results posted: No

Publications

Trnkova L, Burikova M, Soltysova A, Ficek A, Plava J, Cumova A, Rojikova L, Jakic K, Sedlackova E, Tichy B, Bystry V, Busato F, Shen Y, Matuskova M, Kucerova L, Oy GF, Maelandsmo GM, Fleischer T, Tost J, Miklikova S, Cihova M, Buocikova V, Smolkova B. Molecular profiling of chemotherapy-resistant breast cancer reveals DNA methylation remodeling associated with the acquisition of paclitaxel resistance. Drug Resist Updat. 2026 Mar;85:101350. doi: 10.1016/j.drup.2026.101350. Epub 2026 Jan 2.
PubMed 41529624
Hoglander EK, Nord S, Wedge DC, Lingjaerde OC, Silwal-Pandit L, Gythfeldt HV, Vollan HKM, Fleischer T, Krohn M, Schlitchting E, Borgen E, Garred O, Holmen MM, Wist E, Naume B, Van Loo P, Borresen-Dale AL, Engebraaten O, Kristensen V. Time series analysis of neoadjuvant chemotherapy and bevacizumab-treated breast carcinomas reveals a systemic shift in genomic aberrations. Genome Med. 2018 Nov 29;10(1):92. doi: 10.1186/s13073-018-0601-y.
PubMed 30497530
Reinertsen KV, Engebraaten O, Loge JH, Cvancarova M, Naume B, Wist E, Edvardsen H, Wille E, Bjoro T, Kiserud CE. Fatigue During and After Breast Cancer Therapy-A Prospective Study. J Pain Symptom Manage. 2017 Mar;53(3):551-560. doi: 10.1016/j.jpainsymman.2016.09.011. Epub 2016 Dec 29.
PubMed 28042070

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?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Phase II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadjuvant Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Reference to the Obtained Responses in Patients With Large Primary HER2 Negative Breast Cancers
ClinicalTrials.gov ID: NCT00773695
Acronym / sponsor ID: ML21744
Conditions: Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Collaborators: Norwegian Radium Hospital
Study start: 7 Nov 2008 (actual)
Primary completion: 9 Nov 2022 (actual)
Study completion: 9 Nov 2022 (actual)
First posted: 16 Oct 2008 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Chemotherapy	Active comparator	Drug: Epirubicine, Drug: 5-Fluorouracil (5FU), Drug: Cyclophosphamide, Drug: Paclitaxel, Drug: DocetaxelParticipants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks.
Chemotherapy and Bevacizumab	Experimental	Drug: Bevacizumab, Drug: Epirubicine, Drug: 5-Fluorouracil (5FU), Drug: Cyclophosphamide, Drug: Paclitaxel, Drug: DocetaxelParticipants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Participants will also receive concurrent treatment with bevacizumab every 3 weeks for 24 weeks.
Endocrine Therapy	Active comparator	Drug: Aromatase InhibitorParticipants will receive aromatase inhibitor therapy at discretion of the investigator for a period of 24 weeks.
Endocrine Therapy and Bevacizumab	Experimental	Drug: Aromatase Inhibitor, Drug: BevacizumabParticipants will receive aromatase inhibitor therapy at discretion of the investigator and concurrent treatment with bevacizumab for a period of 24 weeks.

Who may qualify

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

Key inclusion criteria (3 listed)

Histologically or cytologically confirmed, HER2-negative, men or pre- or post-menopausal women with primary operable adenocarcinoma of the breast, greater than or equal to (>=) 2.5 centimeters (cm) in size
Eastern Cooperative Oncology Group (ECOG)/world health organization (WHO) performance status less than or equal to (</=) 2
Normal baseline cardiac function (Left Ventricular Ejection Fraction [LVEF])

Key exclusion criteria (5 listed)

Stage IV (metastatic) disease
Previous treatment for localized breast cancer less than (<) 24 months from diagnosis of present breast cancer
Other previous or current cancer except for basal cell cancer or in situ cervical cancer
Current or recent use of aspirin (greater than [>] 325 milligrams per day)
Clinically significant cardiovascular disease

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
Aromatase InhibitorParticipants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.	Drug	Endocrine Therapy, Endocrine Therapy and Bevacizumab
BevacizumabAlso: AvastinBevacizumab will be administered at a dose of 15 mg/kg as IV infusion every 3 weeks (or 10 mg/kg every other week in participants receiving weekly paclitaxel), for 24 weeks.	Drug	Chemotherapy and Bevacizumab, Endocrine Therapy and Bevacizumab
EpirubicineParticipants will receive epirubicine at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.	Drug	Chemotherapy, Chemotherapy and Bevacizumab
5-Fluorouracil (5FU)Participants will receive 5FU at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.	Drug	Chemotherapy, Chemotherapy and Bevacizumab
CyclophosphamideParticipants will receive cyclophosphamide at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.	Drug	Chemotherapy, Chemotherapy and Bevacizumab
PaclitaxelParticipants will receive paclitaxel at a dose of 80 mg/m^2 as IV infusion every week for 12 weeks.	Drug	Chemotherapy, Chemotherapy and Bevacizumab
DocetaxelParticipants will receive docetaxel at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.	Drug	Chemotherapy, Chemotherapy and Bevacizumab

Primary outcome

Percentage of Participants With Messenger Ribonucleic Acid (mRNA) Markers of Pathological Complete Response, as Assessed by Magnetic Resonance Imaging (MRI)
Time frame: Baseline up to end of study treatment (approximately 24 weeks)

22 secondary outcomes

Percentage of Participants With Objective Pathological Complete Response, as Assessed by Clinical Assessment
Time frame: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Type of Surgery
Time frame: At Surgery (Between Weeks 24 and 25)
Percentage of Participants With Axillary Lymph Node Dissection Performed
Time frame: At Surgery (Between Weeks 24 and 25)
Pathological Tumor Size, as Assessed by Histopathological Examination
Time frame: At Surgery (Between Weeks 24 and 25)
Percentage of Participants With Presence of Tumor Cells Close to Resection Margin
Time frame: At Surgery (Between Weeks 24 and 25)
Percentage of Participants With Tumor Deposit in Other Body Parts
Time frame: At Surgery (Between Weeks 24 and 25)
Tumor Free Resection Margin
Time frame: At Surgery (Between Weeks 24 and 25)
Pathological Tumor Size as Measure Using Caliper
Time frame: Cycles 1 to 10 (cycle length=21 days), and Week 25
Pathological Tumor Size as Measure Using MRI
Time frame: Baseline, Weeks 12 and 25
Pathological Tumor Size as Measure Using Mamography
Time frame: Baseline, Weeks 12 and 25
Pathological Breast Tumor Size as Measure Using Ultrasound
Time frame: Baseline, Weeks 12 and 25
Pathological Axilla Tumor Size as Measure Using Ultrasound
Time frame: Baseline, Weeks 12 and 25
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Screening, Cycles 1 to 10 (cycle length=21 days), and Week 25
Percentage of Participants With Lymph Node Involvement
Time frame: Cycles 1 to 10 (cycle length=21 days), and Week 25
Percentage of Participants With Objective Tumor Response, as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Weeks 12 and 25
Percentage of Participants With New Lesions
Time frame: Weeks 12 and 25
Percentage of Participants With Molecular Changes in Protein Kinase Expression
Time frame: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Molecular Changes in Messenger Ribonucleic Acid (mRNA)/microRNA(miRNA)
Time frame: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Molecular Changes in Protein Expression
Time frame: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Single Nucleotide Polymorphism (SNP) Profiles Predicting Treatment Response
Time frame: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Disseminated Tumor Cells in Bone Marrow
Time frame: Baseline up to end of study treatment (approximately 24 weeks)
Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Circulating Tumor Cells in Peripheral Blood
Time frame: Baseline up to end of study treatment (approximately 24 weeks)

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 9 Jan 2023.
Derived from this study: PubMed 41529624Trnkova L, Burikova M, Soltysova A, Ficek A, Plava J, Cumova A, Rojikova L, Jakic K, Sedlackova E, Tichy B, Bystry V, Busato F, Shen Y, Matuskova M, Kucerova L, Oy GF, Maelandsmo GM, Fleischer T, Tost J, Miklikova S, Cihova M, Buocikova V, Smolkova B. Molecular profiling of chemotherapy-resistant breast cancer reveals DNA methylation remodeling associated with the acquisition of paclitaxel resistance. Drug Resist Updat. 2026 Mar;85:101350. doi: 10.1016/j.drup.2026.101350. Epub 2026 Jan 2.
Derived from this study: PubMed 30497530Hoglander EK, Nord S, Wedge DC, Lingjaerde OC, Silwal-Pandit L, Gythfeldt HV, Vollan HKM, Fleischer T, Krohn M, Schlitchting E, Borgen E, Garred O, Holmen MM, Wist E, Naume B, Van Loo P, Borresen-Dale AL, Engebraaten O, Kristensen V. Time series analysis of neoadjuvant chemotherapy and bevacizumab-treated breast carcinomas reveals a systemic shift in genomic aberrations. Genome Med. 2018 Nov 29;10(1):92. doi: 10.1186/s13073-018-0601-y.
Derived from this study: PubMed 28042070Reinertsen KV, Engebraaten O, Loge JH, Cvancarova M, Naume B, Wist E, Edvardsen H, Wille E, Bjoro T, Kiserud CE. Fatigue During and After Breast Cancer Therapy-A Prospective Study. J Pain Symptom Manage. 2017 Mar;53(3):551-560. doi: 10.1016/j.jpainsymman.2016.09.011. Epub 2016 Dec 29.

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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.

Clinical Trials study director

Hoffmann-La Roche

3 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 Aromatase Inhibitor, Bevacizumab and Epirubicine in people with Breast Cancer, run by Hoffmann-La Roche at 3 sites in Norway.

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 5 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 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. 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?

Percentage of Participants With Messenger Ribonucleic Acid (mRNA) Markers of Pathological Complete Response, as Assessed by Magnetic Resonance Imaging (MRI) (time frame: Baseline up to end of study treatment (approximately 24 weeks)). 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 NCT00773695, which also lists 3 linked publications.

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 9 Jan 2023.