Breast CancerPhase 1/2NCT01216176
A Pharmacokinetic and Randomized Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
A Phase 1/2 study testing Anastrozole and AZD0530 (saracatinib) in people with Breast Cancer, run by Joyce Marie Slingerland, MD at 2 sites in United States.
Trial summary
The investigators propose to conduct a Phase I/randomized Phase II study design in order to test the tolerability and efficacy of AZD0530 (also called saracatinib) when used together with anastrozole in therapy for ER+ and/or PR+, postmenopausal breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrozole and AZD0530 (saracatinib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2008to 7 Feb 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Female patient ≥ 18 years
- Patient must be postmenopausal, verified by 1 of the following:
- Bilateral surgical oophorectomy
- No spontaneous menses > 1 year
- No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry
- Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor
Show all 39Show fewer
- Stage IV disease (as defined by the AJCC Staging Manual, 6th Edition, 2002); or locally relapsed, unresectable disease
- Measurable or evaluable disease according to RECIST criteria (see appendix VII)
- Both HER2-positive and HER2-negative disease (as defined by IHC or by fluorescence in situ hybridization [FISH]). HER2+ must have had prior treatment with trastuzumab and/or lapatinib.
- ECOG performance status 0-2 (see appendix VI)
- Patients are suitable candidates for treatment with anastrozole (patients may have had any prior endocrine therapy or prior chemotherapy for treatment of their disease, either as adjuvant therapy, or as treatment for advanced disease). There is no restriction on the number of prior regimens in the phase I cohort A.
- Patient is accessible and willing to comply with treatment and follow-up
- Patient is willing to provide written informed consent prior to the performance of any study-related procedures
- Required laboratory values
- Absolute neutrophil count ≥ to 1.5 x 10^9/L
- Hemoglobin ≥ to 9.0 g/dL
- Platelet count ≥ to 100 x 10^9/L
- Creatinine ≤ 1.5 mg/dL
- Total bilirubin ≤ 1.0 x upper limit of normal (ULN)
- Alkaline phosphatase and AST/ALT within protocol parameters. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used.
- Female patient ≥ 18 years
- Patient must be postmenopausal, verified by 1 of the following:
- Bilateral surgical oophorectomy
- No spontaneous menses ≥ 1 year
- No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry
- Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor. Patients may have bilateral or multifocal invasive breast cancers. The patient may have concurrent DCIS in either breast but the DCIS will not be measured as part of the study endpoints.
- Tumor size ≥ 2 cm
- Tumor measurable either by clinical examination, mammography, MRI, or ultrasound
- HER2-negative disease (as defined by fluorescence in situ hybridization [FISH] or by IHC)
- ECOG performance status 0-1 (see Appendix VI)
- Patient is accessible and willing to comply with treatment and follow-up
- Patient is willing to provide written informed consent prior to the performance of any study-related procedures
- Required laboratory values
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 70 x 10^9/L
- Creatinine ≤ 1.5 mg/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Alkaline phosphatase and AST/ALT ≤ 1.5 x upper limit of normal (ULN)
Who cannot join
- Concurrent therapy with any other non-protocol anti-cancer therapy
- Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration.
- Ongoing, chronic administration of bisphosphonate therapy is allowed so long as such treatment was ongoing at the time of study entry.
- Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped prior to randomization)
- Presence of neuropathy ≥ grade 2 (NCI-CTC version 3.0) at baseline
- History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
Show all 33Show fewer
- Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Active, uncontrolled infection requiring parenteral antimicrobials
- A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 or their excipients
- Evidence of bleeding diathesis or coagulopathy.
- Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.
- Since AZD0530 is a substrate and inhibitor of CYP3A4, patients requiring medication with drugs listed in Appendix XI should be excluded from study.
- Any evidence of severe or uncontrolled systemic medical or psychiatric conditions (e.g. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
- Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry, interstitial pulmonary infiltrates on high resolution CT scan prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) metastasis.
- Prior chemotherapy, endocrine therapy or radiotherapy for the presenting breast cancer. Prior incidence and treatment of contralateral invasive or non-invasive breast cancer is not an exclusion criterion.
- Inflammatory breast cancer, clinically defined as the presence of erythema or induration involving one-third or more of the breast, or pathologically defined as dermal lymphatic invasion
- Prior excisional biopsy or complete resection of the primary invasive tumor (prior sentinel node biopsy allowed)
- Prior ipsilateral radiation therapy for invasive or non-invasive breast cancer
- Distant metastasis is an exclusion criterion - Isolated ipsilateral supraclavicular node involvement and/or direct invasion of the primary tumor into skin is allowed
- Concurrent therapy with any other non-protocol anti-cancer therapy
- Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration
- Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped for one week prior to randomization)
- Presence of neuropathy ≥ grade 2 (NCI-CTC AE version 3.0) at baseline
- History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
- Clinically significant cardiovascular disease (e.g. history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Active, uncontrolled infection requiring parenteral antimicrobials
- A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 (saracatinib) or their excipients
- Evidence of bleeding diathesis or coagulopathy
- Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.
- AZD0530 (saracatinib) is a substrate and inhibitor of CYP3A4. Since concurrent administration of AZD0530 with other CYP3A4 substrates has been shown to be well tolerated, continuation or initiation of medically indicated drugs that are substrates of CYP3A4 is permitted at MD discretion. Drugs listed in Appendix X that are known to strongly induce or inhibit CYP3A4 activity should be discontinued prior to study entry and should not be initiated during protocol treatment.
- Any evidence of severe or uncontrolled systemic psychiatric or medical conditions (eg. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
- Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) disease.
- Subjects unwilling or unable to undergo breast MRI as required by protocol will be excluded from study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Miami, Florida, 33136
Stanford University
Palo Alto, California, 94304
About this study
Official title: A Phase I Pharmacokinetic and Randomized Phase II Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
The investigators propose to conduct a Phase I/randomized Phase II study design in order to test the tolerability and efficacy of AZD0530 (also called saracatinib) when used together with anastrozole in therapy for ER+ and/or PR+, postmenopausal breast cancer. The Phase I pharmacokinetic (PK) cohort of the study (cohort A) in postmenopausal women with metastatic breast cancer 2008-2009 showed initial safety,tolerability and good bioavailability of both drugs and determined the doses for use in the ongoing Phase II trial. In the randomized Phase II cohort of the study (cohort B), postmenopausal women with newly diagnosed, previously untreated ER+, HER2 negative breast cancer that is at least 2 cm or more in diameter by clinical exam or radiology will be randomized to either neoadjuvant treatment with anastrozole plus placebo, or anastrozole in combination with AZD0530 (saracatinib). The Phase II cohort will permit extended assays of tolerability, initial estimates of efficacy, and the investigation of molecular predictors of drug efficacy.
- Conditions
- Breast Cancer
- Being tested
- Anastrozole, AZD0530 (saracatinib), Placebo
- Keywords
- Breast Cancer, Postmenopausal, Metastatic Phase I ONLY, AZD0530 (saracatinib), Anastrozole, Phase I for metastatic disease, Phase II for newly diagnosed breast cancer, Pharmacokinetic, PK, Hormone Receptor, Estrogen Receptor, Progesterone Receptor, ER+, PR+, HER negative, Aromatase Inhibitors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
AZD0530 (saracatinib)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 - Cohort A | Experimental | Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 (saracatinib) 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer Receives: Drug: Anastrozole; Drug: AZD0530 (saracatinib) |
| Phase 2 - Cohort B [Anastrozole + AZD0530] | Active comparator | Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 (saracatinib) 175 mg orally once daily, or as specified per protocol, until disease progression or 4-6 months of treatment completed. Receives: Drug: Anastrozole; Drug: AZD0530 (saracatinib) |
| Phase 2 - Cohort B [Anastrozole + Placebo] | Placebo comparator | Dual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. Receives: Drug: Anastrozole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole
To identify a well tolerated dose of AZD0530 (saracatinib) that can be used together with anastrozole in the Phase 2 trial with tolerable toxicity and PK, subjects were followed as AEs recorded and evaluated and drug concentrations were in the therapeutic range.
Measured: Cycle 1: Days 1 - 28
Phase II - Cohort B: Compare Treatment Groups (AZD0530 + Anastrozole Versus Anastrozole With Placebo) With Respect to Clinical Response
Clinical response is defined as percentage change in tumor size calculated from bi-dimensional clinical tumor measurement at diagnosis and on completion of neoadjuvant treatment. The mean reduction in tumor size ( +/-SD) will be derived form the change in largest tumor dimension ( RECIST) and by calculated tumor volume
Measured: Baseline, cycle 6
Secondary outcomes (7)
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole
Summarized as mean plasma concentrations (ng/ml) of each drug (AZD0530 (saracatinib) and Anastrozole) after exposure to dual therapy.
Measured: 0 hrs, 6 hrs, 12 hrs, 24hrs, 48 hrs, 72 hrs, 8 days, 15 days, 22 days after first dose of AZD0530
Phase 1-Cohort A: Peak Concentration of Each Study Drug ( AZD0530 (Saracatinib) and Anastrozole)
Summarized as the geometric means and standard deviations for the corresponding for peak plasma concentration of each study drug ( AZD0530 (saracatinib) and anastrozole) after exposure
Measured: 0 hrs, 6 hrs, 12 hrs, 24hrs, 48 hrs, 72 hrs, 7 days, 14 days, 21 days after first dose of AZD0530
Phase II Cohort B: Change in Tumor Size by Comparison of Serial MRI
MRI will be used to compare tumor size at baseline and at 10 weeks. MRI will also be used to compare tumor size at baseline and after completion of 6 months of study medication or disease progression.
Measured: Baseline to 10 weeks;and baseline to 6 months
Phase II - Cohort B: Number of Participants With Pathologic Complete Response (pCR)
A pathologic complete response will be defined as the absence of viable tumor cells in the resected specimen, as determined by standard histologic examination. All specimens will be reviewed by a central pathologist to determine pathologic response.
Measured: At completion of 4-6 cycles of therapy or after disease progression
Phase II - Cohort B: The Number of Participants Achieving Clinical Benefit Defined as Complete Response (CR), or Partial Response (PR) or Stable Disease (SD)
Based on physician measurement of tumor size and by MRI measurements of tumor volume using RECIST criteria
Measured: At the end of neoadjuvant therapy
Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole
Blood draws at protocol-specified timepoints to determine mean blood levels of drug for each of AZD0530 and Anastrozole.
Measured: Day 28, 56, 84
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo
Cinically significant AEs defined as clinically significant changes in the patient's symptoms, physical examination and clinical laboratory results are reported as toxicity for AZD0530 (saracatinib) given with anastrozole and for anastrozole given with placebo
Measured: From day 1 of treatment until a maximum of 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study start21 Oct 2008
- Primary completion7 Feb 2018
- Study completion7 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joyce Marie Slingerland, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor-investigator, Joyce Marie Slingerland, MD, University of Miami
- Investigators
- Joyce Slingerland, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216176
- Sponsor's protocol ID
- 20080325
- Other IDs
- SCCC-2008002
- Status last verified
- Dec 2024
- First submitted
- 5 Oct 2010
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pharmacokinetic and Randomized Phase II Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01216176
- Acronym / sponsor ID
- 20080325
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Postmenopausal, Metastatic Phase I ONLY, AZD0530 (saracatinib), Anastrozole, Phase I for metastatic disease, Phase II for newly diagnosed breast cancer, Pharmacokinetic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Joyce Marie Slingerland, MDUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 21 Oct 2008 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 7 Feb 2018 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Posted 31 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to conduct a Phase I/randomized Phase II study design in order to test the tolerability and efficacy of AZD0530 (also called saracatinib) when used together with anastrozole in therapy for ER+ and/or PR+, postmenopausal breast cancer. The Phase I pharmacokinetic (PK) cohort of the study (cohort A) in postmenopausal women with metastatic breast cancer 2008-2009 showed initial safety,tolerability and good bioavailability of both drugs and determined the doses for use in the ongoing Phase II trial. In the randomized Phase II cohort of the study (cohort B), postmenopausal women with newly diagnosed, previously untreated ER+, HER2 negative breast cancer that is at least 2 cm or more in diameter by clinical exam or radiology will be randomized to either neoadjuvant treatment with anastrozole plus placebo, or anastrozole in combination with AZD0530 (saracatinib). The Phase II cohort will permit extended assays of tolerability, initial estimates of efficacy, and the investigation of molecular predictors of drug efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - Cohort A | Experimental | Drug: Anastrozole, Drug: AZD0530 (saracatinib)Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 (saracatinib) 175 mg orally once daily, or as specified per protocol, until disease progression for treatment of metastatic breast cancer |
| Phase 2 - Cohort B [Anastrozole + AZD0530] | Active comparator | Drug: Anastrozole, Drug: AZD0530 (saracatinib)Dual treatment with 1 mg anastrozole orally once daily together with AZD0530 (saracatinib) 175 mg orally once daily, or as specified per protocol, until disease progression or 4-6 months of treatment completed. |
| Phase 2 - Cohort B [Anastrozole + Placebo] | Placebo comparator | Drug: Anastrozole, Drug: PlaceboDual treatment with 1 mg anastrozole orally once daily together with Placebo orally once daily, or as specified per protocol, until disease progression or4-6 months of treatment completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Female patient ≥ 18 years
- Patient must be postmenopausal, verified by 1 of the following:
- Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor
- Stage IV disease (as defined by the AJCC Staging Manual, 6th Edition, 2002); or locally relapsed, unresectable disease
- Measurable or evaluable disease according to RECIST criteria (see appendix VII)
Key exclusion criteria (33 listed)
- Concurrent therapy with any other non-protocol anti-cancer therapy
- Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped prior to randomization)
- Presence of neuropathy ≥ grade 2 (NCI-CTC version 3.0) at baseline
- History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
- Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
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 |
|---|---|---|
| Anastrozole | Drug | Phase 1 - Cohort A, Phase 2 - Cohort B [Anastrozole + AZD0530], Phase 2 - Cohort B [Anastrozole + Placebo] |
| AZD0530 (saracatinib) | Drug | Phase 1 - Cohort A, Phase 2 - Cohort B [Anastrozole + AZD0530] |
| Placebo | Drug | Phase 2 - Cohort B [Anastrozole + Placebo] |
Primary outcome
Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole
Time frame: Cycle 1: Days 1 - 28
To identify a well tolerated dose of AZD0530 (saracatinib) that can be used together with anastrozole in the Phase 2 trial with tolerable toxicity and PK, subjects were followed as AEs recorded and evaluated and drug concentrations were in the therapeutic range.
Phase II - Cohort B: Compare Treatment Groups (AZD0530 + Anastrozole Versus Anastrozole With Placebo) With Respect to Clinical Response
Time frame: Baseline, cycle 6
Clinical response is defined as percentage change in tumor size calculated from bi-dimensional clinical tumor measurement at diagnosis and on completion of neoadjuvant treatment. The mean reduction in tumor size ( +/-SD) will be derived form the change in largest tumor dimension ( RECIST) and by calculated tumor volume
7 secondary outcomes
Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole
Time frame: 0 hrs, 6 hrs, 12 hrs, 24hrs, 48 hrs, 72 hrs, 8 days, 15 days, 22 days after first dose of AZD0530
Phase 1-Cohort A: Peak Concentration of Each Study Drug ( AZD0530 (Saracatinib) and Anastrozole)
Time frame: 0 hrs, 6 hrs, 12 hrs, 24hrs, 48 hrs, 72 hrs, 7 days, 14 days, 21 days after first dose of AZD0530
Phase II Cohort B: Change in Tumor Size by Comparison of Serial MRI
Time frame: Baseline to 10 weeks;and baseline to 6 months
Phase II - Cohort B: Number of Participants With Pathologic Complete Response (pCR)
Time frame: At completion of 4-6 cycles of therapy or after disease progression
Phase II - Cohort B: The Number of Participants Achieving Clinical Benefit Defined as Complete Response (CR), or Partial Response (PR) or Stable Disease (SD)
Time frame: At the end of neoadjuvant therapy
Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole
Time frame: Day 28, 56, 84
Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo
Time frame: From day 1 of treatment until a maximum of 6 months of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joyce Slingerland, MD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anastrozole and AZD0530 (saracatinib) in people with Breast Cancer, run by Joyce Marie Slingerland, MD at 2 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 39 inclusion and 33 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 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole (time frame: Cycle 1: Days 1 - 28). The study lists 2 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 8 Jan 2025.