Breast CancerNCT00897702
Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to learn why certain drugs stop working in patients.In lab studies, tumors become resistant in several ways. Specific molecules seem to change and this may be why therapy stops working. However, we do not know if the same molecules change in patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood draw, immunoenzyme technique and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 269 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Jan 2007to 23 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
Who may be able to join
- All patients:
- Diagnosed with breast cancer.
- Patient must be able to consent to a biopsy
- Patient must be able to safely undergo a secondary biopsy, if needed.
- Cohort 1
- Patients who previously received treatment with anti-HER2 therapy (including trastuzumab, pertuzumab, TDM1, lapatinib, neratibin, or DS8201) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-HER2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced.
Show all 12Show fewer
- Evidence of disease progression or recurrence after prior therapy (e.g. radiologic progression by RECIST criteria or new metastasis).
- Prior tumor biopsy (may be original) defined as HER2+ by amplification by FISH (>1.9 gene copy number) or IHC 3+.
- Cohort 2
- Patients who previously received treatment with hormonal therapy (including aromatase inhibitors or SERMs or SERDs) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression.
- Cohort 3
- Patients not eligible for Cohorts 1 or 2.
Who cannot join
- Patients who are unable to consent to a biopsy.
- Patients for whom a repeat biopsy would be medically unsafe
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553
About this study
The purpose of this study is to learn why certain drugs stop working in patients.In lab studies, tumors become resistant in several ways. Specific molecules seem to change and this may be why therapy stops working. However, we do not know if the same molecules change in patients. This study is being done to see if they do change. If we learn more about how patients become resistant, we may be able to offer better treatment in the future.
- Conditions
- Breast Cancer
- Being tested
- Blood draw, immunoenzyme technique, biopsy, histopathologic examination
- Keywords
- recurrent breast cancer, male breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
A single 10ml tube of blood will also be obtained for a comparison of patient's normal DNA for genomic analyses either at the time of the procedure or at a followup appointment if feasible.
immunoenzyme techniqueOther
biopsyProcedure or surgery
histopathologic examinationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To look for mutations in druggable oncogenic pathways in tumors progressing on anti-HER2 therapy or hormonal therapy
Measured: 3 years
To characterize the activity of the PI3K signaling pathway in progressive breast tumors using proteomic methods
Measured: 3 years
To develop new laboratory models of treatment refractory breast cancer from human tumor specimens
Measured: 3 years
Secondary outcomes (3)
To look for mutations in druggable oncogenic pathways in tumor progressing on breast cancer targeted therapies
Measured: 3 years
To evaluate dynamic proteomic changes in response to inhibition of the RTK/PI3K/ATK/mTOR pathway.
Measured: 3 years
To characterize the genetic heterogeneity of progressive, metastatic tumors using next generation sequencing
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start9 Jan 2007
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
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 Memorial Sloan Kettering Cancer 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
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sarat Chandarlapaty, MD, PhD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897702
- Sponsor's protocol ID
- 06-163
- Other IDs
- MSKCC-06163
- Status last verified
- Jan 2026
- First submitted
- 9 May 2009
- Last updated
- 28 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00897702
- Acronym / sponsor ID
- 06-163
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, male breast cancer, stage IV breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Jan 2007 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 12 May 2009 (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 learn why certain drugs stop working in patients.In lab studies, tumors become resistant in several ways. Specific molecules seem to change and this may be why therapy stops working. However, we do not know if the same molecules change in patients. This study is being done to see if they do change. If we learn more about how patients become resistant, we may be able to offer better treatment in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
Key inclusion criteria (12 listed)
- Diagnosed with breast cancer.
- Patient must be able to consent to a biopsy
- Patient must be able to safely undergo a secondary biopsy, if needed.
- Cohort 1
- Patients who previously received treatment with anti-HER2 therapy (including trastuzumab, pertuzumab, TDM1, lapatinib, neratibin, or DS8201) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-HER2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced.
Key exclusion criteria (2 listed)
- Patients who are unable to consent to a biopsy.
- Patients for whom a repeat biopsy would be medically unsafe
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 |
|---|---|---|
| Blood drawA single 10ml tube of blood will also be obtained for a comparison of patient's normal DNA for genomic analyses either at the time of the procedure or at a followup appointment if feasible. | Other | – |
| immunoenzyme technique | Other | – |
| biopsy | Procedure or surgery | – |
| histopathologic examination | Procedure or surgery | – |
Primary outcome
To look for mutations in druggable oncogenic pathways in tumors progressing on anti-HER2 therapy or hormonal therapy
Time frame: 3 years
To characterize the activity of the PI3K signaling pathway in progressive breast tumors using proteomic methods
Time frame: 3 years
To develop new laboratory models of treatment refractory breast cancer from human tumor specimens
Time frame: 3 years
3 secondary outcomes
To look for mutations in druggable oncogenic pathways in tumor progressing on breast cancer targeted therapies
Time frame: 3 years
To evaluate dynamic proteomic changes in response to inhibition of the RTK/PI3K/ATK/mTOR pathway.
Time frame: 3 years
To characterize the genetic heterogeneity of progressive, metastatic tumors using next generation sequencing
Time frame: 3 years
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 28 Jan 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Sarat Chandarlapaty, MD, PhD study chair
Memorial Sloan Kettering Cancer Center
7 sites 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 Memorial Sloan Kettering Cancer Center at 7 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 12 inclusion and 2 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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?
To look for mutations in druggable oncogenic pathways in tumors progressing on anti-HER2 therapy or hormonal therapy (time frame: 3 years). The study lists 3 primary outcomes in all. 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 28 Jan 2026.