Breast CancerNCT00916162
Drug Withdrawal in Women With Progressive Breast Cancer While on Aromatase Inhibitor Therapy
An observational study of Breast Cancer, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The purpose of this research study is to study the effects of stopping aromatase inhibitory (AI) therapy on breast cancer progression. Aromatase inhibitors are a class of drugs used to treat breast cancer in postmenopausal women. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2006to Jan 2010
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from hopsitals and clinics of the Dana-Farber/Harvard Cancer Center.
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the breast with radiographically documented progressive or recurrent local-regional or metastatic disease. Disease must not be considered amenable to curative treatment
- Evidence of hormone sensitivity (ER +ve and/or PR +ve) of primary or secondary tumor tissue
- Measurable or nonmeasurable (but evaluable-defined as nontarget lesions) disease according to modified RECIST. Patients with bone disease are eligible. These patients will be evaluable only for the presence of stable or progressive disease and not a PR or CR. Patients wih bone-only metastatic disease will be considered to have stable disease if there is no evidence of new lesions and no clear progression of existing lesions
- Postmenopausal, defined as fulfilling any of the following criteria: If > 50 year, no menses within past 12 months, OR if < 50 years, no menses within past 12 months AND FSH within post menopausal range OR bilateral oophorectomy
- Current AI monotherapy at the time of documented disease progression
- AI therapy must be discontinued at time of study entry or no longer than two weeks prior to study entry
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- Subjects receiving AI therapy for metastatic disease at the time of progression, must have had a prior radiographic documented response to AI therapy or have been on therapy for at least 6 months
- Subjects receiving AI as adjuvant therapy at the time of recurrence, must have been treated with AI therapy for at least 12 months
- Prior antiestrogen therapies including tamoxifen, steroidal AIs, nonsteroidal AIs, or faslodex in either the adjuvant or metastatic settings are allowed provided the patient is currently on AI monotherapy (or within two weeks of discontinuation) and has demonstrated a response or stable disease on the current AI
- Female
- Greater than 35 years of age
- ECOG performance status of 0, 1, or 2
Who cannot join
- Premenopausal
- Presence of life threatening metastatic disease, defined as extensive hepatic involvement, any part or present brain or leptomeningeal involvement, or symptomatic pulmonary lymphangitic spread. Subjects with discrete pulmonary parenchymal metastases will not be excluded, as long as their respiratory function is not compromised as a result of pulmonary metastatic disease
- Patients who are highly symptomatic from their breast cancer, or who require urgent palliative chemotherapy, as decided by their treating physician
- Prior or planned radiation therapy to single site of evaluable disease in the event that the site is the only site of evaluable disease
- AST or ALT greater than 5 times the upper limit of normal in teh presence of documented liver metastases
- Any severe concomitant condition believed to render subject undesirable for participation
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- Systemic anticancer therapy including trastuzumab, chemotherapy, or other biologic agents after discontinuation of AI therapy
- Hormone replacement therapy including topical or vaginal estrogen therapy within 3 months prior to discontinuation of AI therapy
- Chronic bisphosphonates for hypercalcemia or for prevention of bone metastases; bisphosphonate therapy at the time of enrollment for documented bone metastases must be continued
- Previous or current systemic malignancy within the past five years except for contralateral breast carcinoma, in situ carcinoma of the cervix treated by cone biopsy, or adequately treated basal or squamous cell carcinoma of the skin. Solid tumors treated greater than 5 years ago and presumed cured are eligible
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Clinical Trial of Drug Withdrawal in Women With Progressive Breast Cancer While on Aromatase Inhibitor Therapy
The purpose of this research study is to study the effects of stopping aromatase inhibitory (AI) therapy on breast cancer progression. Aromatase inhibitors are a class of drugs used to treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen, which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses despite therapy with an AI is thought to have been resistant to AI therapy. There is scientific evidence to suggest that resistant breast cancer cells learn to grow at the very low levels of estrogen present on AI therapy and that increasing estrogen levels even slightly by stopping AI therapy with inhibit the breast cancer cells. An improvement or stabilization of breast cancer has been observed after stopping therapy with tamoxifen, a different anti-estrogen therapy, and has been reported in the literature after stopping AI therapy. This research study will be the first study to formally test the rate of disease improvement (response) or stabilization after stopping AI therapy.
Read the detailed description
- Participants will have the following tests and procedures done at 8 weeks, 16 weeks, and 24 weeks after stopping AI therapy: Physical examination; blood tests; tumor assessment by physical exam (if possible); chest x-ray or CT scan of chest; CT scans of abdomen and pelvis; and bone scan.
- After week 24, these procedures will be repeated every 12 weeks while the participant is on the study.
- Conditions
- Breast Cancer
- Keywords
- aromatase inhibitor
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the clinical benefit rate (CBR) after withdrawal of AI therapy in women with progressive or recurrent breast cancer while on AI therapy.
Measured: 4 years
Secondary outcomes (2)
To estimate time-to-progression (TTP) after withdrawal of AI therapy in women with progressive or recurrent breast cancer while on AI therapy.
Measured: 4 years
To estimate the objective response rate (CR or PR) in patients who have measurable disease as defined by RECIST at baseline.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startAug 2006
- Primary completionJan 2010
- Study completionJan 2010
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 Massachusetts General HospitalThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Goss, MD, PhD, Massachusetts General Hospital
- Investigators
- Paul Goss, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916162
- Sponsor's protocol ID
- 06-091
- Status last verified
- May 2013
- First submitted
- 5 Jun 2009
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Drug Withdrawal in Women With Progressive Breast Cancer While on Aromatase Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT00916162
- Acronym / sponsor ID
- 06-091
- Conditions
- Breast Cancer
- Keywords
- aromatase inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute
- Study start
- Aug 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Jun 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 research study is to study the effects of stopping aromatase inhibitory (AI) therapy on breast cancer progression. Aromatase inhibitors are a class of drugs used to treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen, which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses despite therapy with an AI is thought to have been resistant to AI therapy. There is scientific evidence to suggest that resistant breast cancer cells learn to grow at the very low levels of estrogen present on AI therapy and that increasing estrogen levels even slightly by stopping AI therapy with inhibit the breast cancer cells. An improvement or stabilization of breast cancer has been observed after stopping therapy with tamoxifen, a different anti-estrogen therapy, and has been reported in the literature after stopping AI therapy. This research study will be the first study to formally test the rate of disease improvement (response) or stabilization after stopping AI therapy.
Detailed description
- Participants will have the following tests and procedures done at 8 weeks, 16 weeks, and 24 weeks after stopping AI therapy: Physical examination; blood tests; tumor assessment by physical exam (if possible); chest x-ray or CT scan of chest; CT scans of abdomen and pelvis; and bone scan.
- After week 24, these procedures will be repeated every 12 weeks while the participant is on the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from hopsitals and clinics of the Dana-Farber/Harvard Cancer Center.
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed adenocarcinoma of the breast with radiographically documented progressive or recurrent local-regional or metastatic disease. Disease must not be considered amenable to curative treatment
- Evidence of hormone sensitivity (ER +ve and/or PR +ve) of primary or secondary tumor tissue
- Measurable or nonmeasurable (but evaluable-defined as nontarget lesions) disease according to modified RECIST. Patients with bone disease are eligible. These patients will be evaluable only for the presence of stable or progressive disease and not a PR or CR. Patients wih bone-only metastatic disease will be considered to have stable disease if there is no evidence of new lesions and no clear progression of existing lesions
- Postmenopausal, defined as fulfilling any of the following criteria: If > 50 year, no menses within past 12 months, OR if < 50 years, no menses within past 12 months AND FSH within post menopausal range OR bilateral oophorectomy
- Current AI monotherapy at the time of documented disease progression
Key exclusion criteria (10 listed)
- Premenopausal
- Presence of life threatening metastatic disease, defined as extensive hepatic involvement, any part or present brain or leptomeningeal involvement, or symptomatic pulmonary lymphangitic spread. Subjects with discrete pulmonary parenchymal metastases will not be excluded, as long as their respiratory function is not compromised as a result of pulmonary metastatic disease
- Patients who are highly symptomatic from their breast cancer, or who require urgent palliative chemotherapy, as decided by their treating physician
- Prior or planned radiation therapy to single site of evaluable disease in the event that the site is the only site of evaluable disease
- AST or ALT greater than 5 times the upper limit of normal in teh presence of documented liver metastases
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
To estimate the clinical benefit rate (CBR) after withdrawal of AI therapy in women with progressive or recurrent breast cancer while on AI therapy.
Time frame: 4 years
2 secondary outcomes
To estimate time-to-progression (TTP) after withdrawal of AI therapy in women with progressive or recurrent breast cancer while on AI therapy.
Time frame: 4 years
To estimate the objective response rate (CR or PR) in patients who have measurable disease as defined by RECIST at baseline.
Time frame: 4 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 8 May 2013.
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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.
Paul Goss, MD, PhD principal investigator
Massachusetts General Hospital
3 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 Massachusetts General Hospital at 3 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 10 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 8 May 2013. 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 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 estimate the clinical benefit rate (CBR) after withdrawal of AI therapy in women with progressive or recurrent breast cancer while on AI therapy. (time frame: 4 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 8 May 2013.