Breast CancerNCT02752893
Estrogen Receptor-Positive Breast Cancer Patient-Derived Xenografts
An observational study of Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The investigators will establish a platform at Dartmouth-Hitchcock Medical Center to generate novel models of estrogen receptor alpha-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, which will be used for research studies to develop novel treatment strategies and dissect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2017to 3 Apr 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects >18 years of age with disease progression during neoadjuvant therapy, recurrence after neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic disease that expresses estrogen receptor alpha (ER+) and does not overexpress HER2 (HER2-, HER2-negative). Subjects must be scheduled to undergo a clinically indicated biopsy or surgical removal of tumor, and excess tumor tissue must be available for research use.
Who may be able to join
- Men and women > age 18 with histologically documented ER+/HER2- breast cancer or with a history of ER+/HER2- breast cancer, for whom a tumor biopsy or surgical resection is clinically indicated and will be performed as standard of care.
- Tumor specimens may be from breast (progressive or recurrent) or metastatic sites. Patients with multicentric or bilateral disease are eligible.
- Patients must have disease progression during neoadjuvant therapy, recurrence after neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic disease.
- ER positivity is defined as >10% of malignant tumor cells staining positively for ER by immunohistochemistry (IHC).
- HER2 negativity is defined as IHC 0-1+, or with a fluorescence in situ hybridization (FISH) ratio of <1.8 if IHC is 2+ or if IHC has not been done.
- Excess LIVE tumor tissue must be available from the surgically resected tumor specimen, or from 1-3 extra core needle or incisional biopsy. LIVE tumor tissue must be available within 2 hours of removal from patient (shorter time is preferable).
Show all 10Show fewer
- A recurrent or progressing breast cancer must be greater than 1 cm in greatest diameter.
- Prior therapy is allowed as long as excess viable tumor tissue is available from the biopsy or surgical excision procedure.
- Patients must be willing to provide 6 mL of blood, which can be obtained during a routine clinically indicated blood draw (ideally, done on the same day as the tumor biopsy/surgery).
- Ability to give signed informed consent.
Who cannot join
- 1. Fine needle aspirates and effusions of bodily fluids are not eligible as sources of tumor cells.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The investigators will establish a platform at Dartmouth-Hitchcock Medical Center to generate novel models of estrogen receptor alpha-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, which will be used for research studies to develop novel treatment strategies and dissect signaling pathways underlying drug sensitivity and resistance.
- Conditions
- Breast Cancer
- Keywords
- estrogen, estrogen receptor, ER+, HER2, HER2-, HER2-negative, xenograft, co-clinical, mice, patient-derived xenograft, patient-derived, breast cancer, precision medicine, personalized medicine
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Xenograft success rate, defined as the percentage of patient tumors that yield a growing xenograft in mice.
Measured: 1 year from time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study start30 Jan 2017
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Schwartz, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752893
- Sponsor's protocol ID
- D16100
- Status last verified
- May 2020
- First submitted
- 26 Apr 2016
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Receptor-Positive Breast Cancer Patient-Derived Xenografts
- ClinicalTrials.gov ID
- NCT02752893
- Acronym / sponsor ID
- D16100
- Conditions
- Breast Cancer
- Keywords
- estrogen, estrogen receptor, ER+, HER2, HER2-, HER2-negative, xenograft, co-clinical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 27 Apr 2016 (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 investigators will establish a platform at Dartmouth-Hitchcock Medical Center to generate novel models of estrogen receptor alpha-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, which will be used for research studies to develop novel treatment strategies and dissect signaling pathways underlying drug sensitivity and resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects >18 years of age with disease progression during neoadjuvant therapy, recurrence after neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic disease that expresses estrogen receptor alpha (ER+) and does not overexpress HER2 (HER2-, HER2-negative). Subjects must be scheduled to undergo a clinically indicated biopsy or surgical removal of tumor, and excess tumor tissue must be available for research use.
Key inclusion criteria (10 listed)
- Men and women > age 18 with histologically documented ER+/HER2- breast cancer or with a history of ER+/HER2- breast cancer, for whom a tumor biopsy or surgical resection is clinically indicated and will be performed as standard of care.
- Tumor specimens may be from breast (progressive or recurrent) or metastatic sites. Patients with multicentric or bilateral disease are eligible.
- Patients must have disease progression during neoadjuvant therapy, recurrence after neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic disease.
- ER positivity is defined as >10% of malignant tumor cells staining positively for ER by immunohistochemistry (IHC).
- HER2 negativity is defined as IHC 0-1+, or with a fluorescence in situ hybridization (FISH) ratio of <1.8 if IHC is 2+ or if IHC has not been done.
Key exclusion criteria (1 listed)
- 1. Fine needle aspirates and effusions of bodily fluids are not eligible as sources of tumor cells.
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
Xenograft success rate, defined as the percentage of patient tumors that yield a growing xenograft in mice.
Time frame: 1 year from time of surgery
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 1 Jun 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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?
The sponsor lists 10 inclusion and 1 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 1 Jun 2020. 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?
Xenograft success rate, defined as the percentage of patient tumors that yield a growing xenograft in mice. (time frame: 1 year from time of surgery). 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 1 Jun 2020.