Metastatic Breast CancerNCT01750164
Patient Derived Breast Cancer Xenografts
An observational study of Metastatic Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This study will use tissue or body fluid acquired during standard procedures that are part of the patient's care for their cancer, such as surgery to remove tumor tissue or needle withdrawal of body fluid containing cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Aug 2014
- 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: Women with invasive breast cancer with metastatic disease seen in Oncology clinic
- Women > age 18. with a history of ER+. HER-2 negative breast cancer previously treated with adjuvant anti-estrogen therapy (tamoxifen or aromatase inhibitor? for at least 1 year after surgical resection of primary tumor.
- ER+ status requires positive staining in > 10% of malignant cells in biopsy specimen.
- HER-2 Negative status requires Immunohistochemistry 0-1+, or with a FISH ratio of < 2.0 if IHC is 2+ or if IHC has not been done.
- Patient must have: A. newly diagnosed recurrent, locally advanced or metastatic breast cancer. B. existing advanced or metastatic breast cancer.
- Patient must be having clinically indicated: A. diagnostic tumor biopsy via core-or needle incision or B. surgical removal of tumor or C. collection of pleural or ascetic fluid in order to obtain fresh tumor tissue for research (transplant into mice).
- For subjects having a diagnostic tumor biopsy, excess fresh tumor tissue must be available from the biopsy for research for immediate transplantation into mice.
- For subjects having a surgical resection of the primary tumor, the tumor must have a clinical size of 1 cm or greater, and and excess fresh tumor tissue must be available from the surgical specimen for research for immediate transplantation into mice.
- Ability to give signed informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
This study will use tissue or body fluid acquired during standard procedures that are part of the patient's care for their cancer, such as surgery to remove tumor tissue or needle withdrawal of body fluid containing cancer cells. The tissue or cells will be injected into immune compromised mice and the tissue will be allowed to grow to a tumor 1-1.5 cm size. The tissue will then be extracted and either frozen, embedded in paraffin, or used for engraftment into another generation of mice. The second generation mice will be separated into groups and given various treatments.
Tissue from the participants and from the mouse established tumors, in which the mice have either received treatment or have not received treatment, will be used to evaluate the levels of various genes that assist in regulating cell growth and cell death. The tumor tissue from participants and mice will also be tested for random changes in the genetic material and compared to the participant's blood to determine if any of the changes in the genetic material correlate with better engraftment of the patient tissue in the mice. It is anticipated that 10-30% will have successful engraftment of tumor tissue
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer
- Medical subject headings
- 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 |
|---|---|---|
| Invasive breast cancer with metastatic disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Engraftment
Thirty-five patients with breast cancer will be recruited. We anticipate that 10-30% will have successful engraftment of tumor tissue. The achievement of five successful xenografts would justify additional study.
Measured: 2 years
Secondary outcomes (1)
Time until tumor formation
The rate of tumor growth will be calculated. Mice are monitored three times per week for general health and tumor length. Tumor length Tumor length and width are measured with calipers and recorded. Tumor volume will be calculated with the formula (Length x Width x Width)/2, derived from the formula for the volume of an ellipsoid. Tumor growth will be measured at each time point by calculating the ratio of tumor volume (V) to the initial tumor volume (Vo). Average time, measured in weeks, required for tumors to form palpable masses in F1 mice will be recorded as the Time-until-Tumor-Formation (TTF). A comparison of TTF between tumor cells isolated from tumor tissue isolated by surgical biopsy, and by malignant cells in a body fluid will be compared
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: discontinued funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Schwartz, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750164
- Sponsor's protocol ID
- D12168
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2012
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Derived Breast Cancer Xenografts
- ClinicalTrials.gov ID
- NCT01750164
- Acronym / sponsor ID
- D12168
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: discontinued funding
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Dec 2012 (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.
This study will use tissue or body fluid acquired during standard procedures that are part of the patient's care for their cancer, such as surgery to remove tumor tissue or needle withdrawal of body fluid containing cancer cells. The tissue or cells will be injected into immune compromised mice and the tissue will be allowed to grow to a tumor 1-1.5 cm size. The tissue will then be extracted and either frozen, embedded in paraffin, or used for engraftment into another generation of mice. The second generation mice will be separated into groups and given various treatments.
Tissue from the participants and from the mouse established tumors, in which the mice have either received treatment or have not received treatment, will be used to evaluate the levels of various genes that assist in regulating cell growth and cell death. The tumor tissue from participants and mice will also be tested for random changes in the genetic material and compared to the participant's blood to determine if any of the changes in the genetic material correlate with better engraftment of the patient tissue in the mice. It is anticipated that 10-30% will have successful engraftment of tumor tissue
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive breast cancer with metastatic disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with invasive breast cancer with metastatic disease seen in Oncology clinic
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
Successful Engraftment
Time frame: 2 years
Thirty-five patients with breast cancer will be recruited. We anticipate that 10-30% will have successful engraftment of tumor tissue. The achievement of five successful xenografts would justify additional study.
1 secondary outcome
Time until tumor formation
Time frame: 2 years
Results and safety
The study was stopped early (reason given: discontinued funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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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.
Gary Schwartz, MD principal investigator
Dartmouth-Hitchcock 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 Metastatic Breast Cancer, run by Dartmouth-Hitchcock 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?
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 12 May 2015. 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 was stopped early (reason given: discontinued funding). Results are not available in the source record.
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?
Successful Engraftment (time frame: 2 years). 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 12 May 2015.