Breast CancerPhase 1NCT00253318
RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
A Phase 1 study testing Docetaxel, RAD001 and Dexamethasone in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary: To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment (phase I). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel, RAD001 and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2005to Apr 2012
- Phase
- Phase 1
- 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
Who may be able to join
- 18 years of age or older.
- Diagnosis of metastatic breast cancer with at least one measurable or evaluable lesion. For the phase II portion of the study patients will be required to have measurable disease. Response will be determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- No limit on the prior number of chemotherapies for the phase I portion of the study. No more than one prior chemotherapy regimen for the phase II portion of the study.
- Signed informed consent to participate in the study must be obtained from patients after they have been fully informed on the nature and potential risks by the investigator with the aid of written information.
- Adequate bone marrow function as shown by: Absolute neutrophil count (ANC) > or = 1.5 times 10(9)/L, Platelets > or = 100 times 10(9)/L, Hgb > or = 10g/dL.
- Normal renal function as shown by serum creatinine < or = 1.5 times Upper Limit of Normal (ULN).
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- Hepatic Function Variables:
- Bilirubin < or = ULN
- Alkaline phosphatase < or = 5 times ULN. If alkaline phosphatase is < or = 2.5 times ULN, ALT/AST must be < or = 2.0 times ULN. If alkaline phosphatase is > 2.5 but < or = 5 times ULN, ALT/AST must be < or = 1.5 times ULN
- Performance Status 0-2 on the World Health Organization (WHO) scale.
Who cannot join
- Patients enrolled in the Phase I portion of the trial may have received prior docetaxel in the adjuvant or metastatic setting. Patients enrolled in the Phase II portion of the trial will not be considered eligible if they have received prior docetaxel as treatment for metastatic breast cancer. For the purposes of this protocol, patients who develop systemic metastasis < 6 months from adjuvant docetaxel will be considered to have had treatment with docetaxel for metastatic breast cancer and will be ineligible for protocol participation.
- Patients with a history of thromboembolism within the prior 6 months or active thrombophlebitis.
- For the phase I portion of the study, patients with grade > 2 neuropathy, for the phase II portion of the trial, patients with > or = grade 2 neuropathy.
- For the phase I portion of the trial, patients with treated brain metastasis that are stable for 3 months will be eligible for protocol participation. However, patients with brain metastasis will be excluded from the phase II portion of the trial.
- Patients with an uncontrolled infection.
- Patients with a known history of HIV seropositivity.
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- Patients with an active, bleeding diathesis, or on oral anti-vitamin K medication (except patients receiving 1 mg of warfarin to prevent central venous catheter thrombosis).
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).
- Patients with impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
- Patients who received any other investigational drugs within the preceding 30 days.
- Patients who have received mitomycin C or nitrosourea.
- Patients receiving anti-neoplastic therapy less than 14 days prior to entry onto this study or who have not recovered from the toxic effects of such therapy.
- Patients who received radiation therapy within 3 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy.
- Patients who had surgery within 2 weeks prior to entry on this study or who have not recovered from the side effects of such therapy.
- Patients with a history of noncompliance to medical regimens.
- Patients unwilling to or unable to comply with the protocol.
- Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 or patients taking lithium chloride.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT MD Anderson Cancer Center
Houston, Texas, 77230-1439
About this study
Official title: Phase I, Open Label, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of the Combination RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
Primary:
- To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment (phase I).
- To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase I).
Read more
Secondary:
- To determine the phosphorylation status of the components of the mTOR signaling pathway and the expression of modifiers of apoptosis in the primary breast tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and docetaxel
- To determine the effect of the combination of RAD001 and docetaxel on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination
Read the detailed description
Docetaxel is a drug approved for the treatment of metastatic breast cancer in patients who are either newly diagnosed or have failed earlier chemotherapy. RAD001 is an investigational drug that has shown to have anticancer properties. It also works by weakening the immune system. RAD001 works by blocking some of the steps required for cancer growth. The researcher hopes that RAD001 may increase the anticancer activity of docetaxel.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. Blood (between 1-2 teaspoons) will be collected for routine tests. You will have scans (MRI or CT) to check on the status of your cancer as ordered by your primary physician. Women who are able to have children must have a negative blood pregnancy test. As part of the study researchers will also look at the tissue of your original cancer. Special stains will be done that will help find ways in which researchers can predict the response of your cancer to RAD001.
If you are found to be eligible to take part in this study, you will receive docetaxel by vein on Day 1 over one hour. RAD001 will be given by mouth on Days 1 and 8. RAD 001 will be given on an empty stomach or after a light meal. You will repeat this treatment every 21 days. Three (3 ) weeks equals 1 cycle.
Patients who participate on the first part of this study will be enrolled in groups of 3 at a time. The dose of RAD001 will be increased with each new group of patients. The dose of docetaxel will remain the same. The second part of the study will be using the highest dose of RAD001 and docetaxel that was found to be safe and effective during the first part of the study. (*Study did not progress to second part.*)
Dexamethasone will be given by mouth twice a day for 3 days, starting the day before you receive docetaxel. Dexamethasone helps decrease the risk of and control nausea, vomiting, and fluid retention.
Blood (between 1-2 teaspoons) will be drawn for routine tests at each visit. X-rays and scans (CT or MRI) will be done every 6 weeks to see if the tumor is responding to treatment.
After 6 cycles of the combination, docetaxel will be stopped and you will continue to take RAD001 alone. However, you may be able to take more than 6 cycles of the combination if you are not having any side effects and is found to be of benefit by your primary doctor.
Once you go off treatment, you will have a physical exam, including routine blood tests (1-2 teaspoons).
This is an investigational study. Docetaxel is approved by the FDA and commercially available for the treatment of breast cancer. RAD001 is authorized for use in research only. About 65 patients will take part in the study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, RAD001, Dexamethasone
- Keywords
- Neoplasm Metastasis, Breast Cancer, Docetaxel, RAD001, Taxotere
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
40 mg/m^2 IV over 1 hour on Day 1.
RAD001Drug
30 mg orally on Days 1 and 8.
DexamethasoneDrug
Also called Decadron
8 mg orally twice daily for 3 days, starting 24 hours prior to the administration of Docetaxel.
| Study group | Role | What they receive |
|---|---|---|
| RAD001 + Docetaxel | Experimental | RAD001 30 mg orally on Days 1 and 8. Docetaxel 40 mg/m^2 intravenous (IV) over 1 hour on Day 1. Dexamethasone 8 mg orally twice daily for 3 days, starting 24 hours prior to the administration of Docetaxel. Receives: Drug: Docetaxel; Drug: RAD001; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of combination of RAD001 plus Docetaxel
Measured: 3 week cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study start1 Nov 2005
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Toxicity and Lack of Efficacy
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 M.D. Anderson 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Stacy Moulder, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253318
- Sponsor's protocol ID
- 2004-0758
- Other IDs
- NCI-2010-00840
- Status last verified
- Jun 2026
- First submitted
- 11 Nov 2005
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of the Combination RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00253318
- Acronym / sponsor ID
- 2004-0758
- Conditions
- Breast Cancer
- Keywords
- Neoplasm Metastasis, Breast Cancer, Docetaxel, RAD001, Taxotere
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Toxicity and Lack of Efficacy
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 1 Nov 2005 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 Nov 2005 (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.
Primary:
- To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment (phase I).
- To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase I).
Secondary:
- To determine the phosphorylation status of the components of the mTOR signaling pathway and the expression of modifiers of apoptosis in the primary breast tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and docetaxel
- To determine the effect of the combination of RAD001 and docetaxel on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination
Detailed description
Docetaxel is a drug approved for the treatment of metastatic breast cancer in patients who are either newly diagnosed or have failed earlier chemotherapy. RAD001 is an investigational drug that has shown to have anticancer properties. It also works by weakening the immune system. RAD001 works by blocking some of the steps required for cancer growth. The researcher hopes that RAD001 may increase the anticancer activity of docetaxel.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. Blood (between 1-2 teaspoons) will be collected for routine tests. You will have scans (MRI or CT) to check on the status of your cancer as ordered by your primary physician. Women who are able to have children must have a negative blood pregnancy test. As part of the study researchers will also look at the tissue of your original cancer. Special stains will be done that will help find ways in which researchers can predict the response of your cancer to RAD001.
If you are found to be eligible to take part in this study, you will receive docetaxel by vein on Day 1 over one hour. RAD001 will be given by mouth on Days 1 and 8. RAD 001 will be given on an empty stomach or after a light meal. You will repeat this treatment every 21 days. Three (3 ) weeks equals 1 cycle.
Patients who participate on the first part of this study will be enrolled in groups of 3 at a time. The dose of RAD001 will be increased with each new group of patients. The dose of docetaxel will remain the same. The second part of the study will be using the highest dose of RAD001 and docetaxel that was found to be safe and effective during the first part of the study. (*Study did not progress to second part.*)
Dexamethasone will be given by mouth twice a day for 3 days, starting the day before you receive docetaxel. Dexamethasone helps decrease the risk of and control nausea, vomiting, and fluid retention.
Blood (between 1-2 teaspoons) will be drawn for routine tests at each visit. X-rays and scans (CT or MRI) will be done every 6 weeks to see if the tumor is responding to treatment.
After 6 cycles of the combination, docetaxel will be stopped and you will continue to take RAD001 alone. However, you may be able to take more than 6 cycles of the combination if you are not having any side effects and is found to be of benefit by your primary doctor.
Once you go off treatment, you will have a physical exam, including routine blood tests (1-2 teaspoons).
This is an investigational study. Docetaxel is approved by the FDA and commercially available for the treatment of breast cancer. RAD001 is authorized for use in research only. About 65 patients will take part in the study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001 + Docetaxel | Experimental | Drug: Docetaxel, Drug: RAD001, Drug: DexamethasoneRAD001 30 mg orally on Days 1 and 8. Docetaxel 40 mg/m^2 intravenous (IV) over 1 hour on Day 1. Dexamethasone 8 mg orally twice daily for 3 days, starting 24 hours prior to the administration of Docetaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age or older.
- Diagnosis of metastatic breast cancer with at least one measurable or evaluable lesion. For the phase II portion of the study patients will be required to have measurable disease. Response will be determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- No limit on the prior number of chemotherapies for the phase I portion of the study. No more than one prior chemotherapy regimen for the phase II portion of the study.
- Signed informed consent to participate in the study must be obtained from patients after they have been fully informed on the nature and potential risks by the investigator with the aid of written information.
- Adequate bone marrow function as shown by: Absolute neutrophil count (ANC) > or = 1.5 times 10(9)/L, Platelets > or = 100 times 10(9)/L, Hgb > or = 10g/dL.
Key exclusion criteria (17 listed)
- Patients enrolled in the Phase I portion of the trial may have received prior docetaxel in the adjuvant or metastatic setting. Patients enrolled in the Phase II portion of the trial will not be considered eligible if they have received prior docetaxel as treatment for metastatic breast cancer. For the purposes of this protocol, patients who develop systemic metastasis < 6 months from adjuvant docetaxel will be considered to have had treatment with docetaxel for metastatic breast cancer and will be ineligible for protocol participation.
- Patients with a history of thromboembolism within the prior 6 months or active thrombophlebitis.
- For the phase I portion of the study, patients with grade > 2 neuropathy, for the phase II portion of the trial, patients with > or = grade 2 neuropathy.
- For the phase I portion of the trial, patients with treated brain metastasis that are stable for 3 months will be eligible for protocol participation. However, patients with brain metastasis will be excluded from the phase II portion of the trial.
- Patients with an uncontrolled infection.
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 |
|---|---|---|
| DocetaxelAlso: Taxotere40 mg/m^2 IV over 1 hour on Day 1. | Drug | RAD001 + Docetaxel |
| RAD00130 mg orally on Days 1 and 8. | Drug | RAD001 + Docetaxel |
| DexamethasoneAlso: Decadron8 mg orally twice daily for 3 days, starting 24 hours prior to the administration of Docetaxel. | Drug | RAD001 + Docetaxel |
Primary outcome
Maximum Tolerated Dose (MTD) of combination of RAD001 plus Docetaxel
Time frame: 3 week cycles
Results and safety
The study was stopped early (reason given: Toxicity and Lack of Efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- UT MD Anderson Cancer Center WebsiteLink 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.
Stacy Moulder, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Docetaxel, RAD001 and Dexamethasone in people with Breast Cancer, run by M.D. Anderson Cancer 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 17 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: stopped early, as of the sponsor's last update on 18 Jun 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Toxicity and Lack of Efficacy). 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?
Maximum Tolerated Dose (MTD) of combination of RAD001 plus Docetaxel (time frame: 3 week cycles). 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 18 Jun 2026.