Locally Advanced Breast CancerNCT01048918
Characterization of Circulating Tumor Cells (CTC-s) in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer
An observational study of Locally Advanced Breast Cancer and Metastatic (Stage IV) Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to identify tumor cells in the bloodstream (Circulating Tumor Cells, CTC's) from patient's with locally advanced or metastatic (stage IV) breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Breast Cancer, Metastatic (Stage IV) Breast Cancer, Stage III-IV Breast Cancer or Inflammatory
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2008to 8 Apr 2022
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Brawerman Center-Outpatient clinics (City of Hope), Pasadena Satellite Office
Who may be able to join
- Patients must be > 18 years old.
- Patients are being treated for breast cancer at City of Hope (COH).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
The purpose of this study is to identify tumor cells in the bloodstream (Circulating Tumor Cells, CTC's) from patient's with locally advanced or metastatic (stage IV) breast cancer. Analyzing the tumor is helpful in guiding therapy; however, research has suggested that the number of tumor cells found in the bloodstream (CTC's) signifies more aggressive behavior and increased difficulty in eliminating the cancer. This research will help to develop better ways to treat breast cancer which could be tailored to a patient and may be adjusted to a patient's individual needs.
Read the detailed description
Up to 60 mL of blood will be collected from each patient at up to 6 time points. Samples will be delivered to the Bruce Laboratory (Palo Alto Research Center) for immunolabeling and FAST scanning. The FAST scanning will utilize CK+, CD45-and DAPI+ labeling as well as cell morphology confirmed by collaborating pathologists to select for CTC with the technology allowing for assessment of up to four additional protein expressions on the surface of CTC's. Additional samples at the proposed time points will be placed on ice and sent over to the Wang Laboratory for the purpose of extracting RNA/microRNA and proteins from CTC's for profiling and further analysis. Benefits are only to society, not the individual. Knowledge obtained from applying the two technologies may help with better selection of therapy, early detection of progression, possibly better diagnosis and development of targeted therapeutic agents in the future.
- Conditions
- Locally Advanced Breast Cancer, Metastatic (Stage IV) Breast Cancer, Stage III-IV Breast Cancer or Inflammatory
- Keywords
- Circulating tumor cells in breast cancer
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targets ER, Her2, and possible M30, VEGFR2, EGFR. Tumor cells found in blood stream.
Measured: Blood will be collected at up to 6 time points: Prior to initiating therapy, 8-12 weeks, 20-24 weeks, and at 9,12 and 24 months after initiation of therapy.
Secondary outcomes (1)
Banking leftover blood. Used for future research purposes that have not yet been determined.
Measured: Future
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study start4 Sep 2008
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
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 Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Palo Alto Research Center
- Responsible party
- Sponsor
- Investigators
- Yuan Yuan, MD, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048918
- Sponsor's protocol ID
- 08128
- Other IDs
- CA 111359
- Status last verified
- Jul 2023
- First submitted
- 12 Jan 2010
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Flores LM, Kindelberger DW, Ligon AH, Cappeletti M, Fiorentino M, Loda M, Cibas ES, Janne PA, Krop IE. Dana-Farber Cancer Institute, Boston, MA; Brigham and Women's Hospital, Boston, MA. Comparison of the Cellsearch Profile Kit (CPK) with the Standard Cellsearch Epithelial Kit (CEK) Demonstrates the CPK Produces Higher Circulating Tumor Cell (CTC) Yields and Is Better Suited for Use in Obtaining CTC's for Molecular Characterization. American Association for Cancer Research 2009; 69(Suppl.): (24). December 15, 2009
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Circulating Tumor Cells (CTC-s) in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer
- ClinicalTrials.gov ID
- NCT01048918
- Acronym / sponsor ID
- 08128
- Conditions
- Locally Advanced Breast Cancer, Metastatic (Stage IV) Breast Cancer, Stage III-IV Breast Cancer or Inflammatory
- Keywords
- Circulating tumor cells in breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Palo Alto Research Center
- Study start
- 4 Sep 2008 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 14 Jan 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 purpose of this study is to identify tumor cells in the bloodstream (Circulating Tumor Cells, CTC's) from patient's with locally advanced or metastatic (stage IV) breast cancer. Analyzing the tumor is helpful in guiding therapy; however, research has suggested that the number of tumor cells found in the bloodstream (CTC's) signifies more aggressive behavior and increased difficulty in eliminating the cancer. This research will help to develop better ways to treat breast cancer which could be tailored to a patient and may be adjusted to a patient's individual needs.
Detailed description
Up to 60 mL of blood will be collected from each patient at up to 6 time points. Samples will be delivered to the Bruce Laboratory (Palo Alto Research Center) for immunolabeling and FAST scanning. The FAST scanning will utilize CK+, CD45-and DAPI+ labeling as well as cell morphology confirmed by collaborating pathologists to select for CTC with the technology allowing for assessment of up to four additional protein expressions on the surface of CTC's. Additional samples at the proposed time points will be placed on ice and sent over to the Wang Laboratory for the purpose of extracting RNA/microRNA and proteins from CTC's for profiling and further analysis. Benefits are only to society, not the individual. Knowledge obtained from applying the two technologies may help with better selection of therapy, early detection of progression, possibly better diagnosis and development of targeted therapeutic agents in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Brawerman Center-Outpatient clinics (City of Hope), Pasadena Satellite Office
Key inclusion criteria (2 listed)
- Patients must be > 18 years old.
- Patients are being treated for breast cancer at City of Hope (COH).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Targets ER, Her2, and possible M30, VEGFR2, EGFR. Tumor cells found in blood stream.
Time frame: Blood will be collected at up to 6 time points: Prior to initiating therapy, 8-12 weeks, 20-24 weeks, and at 9,12 and 24 months after initiation of therapy.
1 secondary outcome
Banking leftover blood. Used for future research purposes that have not yet been determined.
Time frame: Future
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 5 Jul 2023.
- Results publicationFlores LM, Kindelberger DW, Ligon AH, Cappeletti M, Fiorentino M, Loda M, Cibas ES, Janne PA, Krop IE. Dana-Farber Cancer Institute, Boston, MA; Brigham and Women's Hospital, Boston, MA. Comparison of the Cellsearch Profile Kit (CPK) with the Standard Cellsearch Epithelial Kit (CEK) Demonstrates the CPK Produces Higher Circulating Tumor Cell (CTC) Yields and Is Better Suited for Use in Obtaining CTC's for Molecular Characterization. American Association for Cancer Research 2009; 69(Suppl.): (24). December 15, 2009
- San Antonio Breast Cancer SymposiumLink provided by the sponsor.
Related trials for Locally Advanced Breast Cancer
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 1
HER2 Vaccine for Locally Advanced Breast Cancer
Breast Cancer, HER2-positive Breast Cancer
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer
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.
Yuan Yuan, MD, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Breast Cancer and Metastatic (Stage IV) Breast Cancer, run by City of Hope Medical Center at 1 site 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 2 inclusion and 0 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 5 Jul 2023. 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 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.
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?
Targets ER, Her2, and possible M30, VEGFR2, EGFR. Tumor cells found in blood stream. (time frame: Blood will be collected at up to 6 time points: Prior to initiating therapy, 8-12 weeks, 20-24 weeks, and at 9,12 and 24 months after initiation of therapy.). 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 NCT01048918, 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 5 Jul 2023.