Breast CancerPhase 2PACT001NCT00570323
Arimidex With or Without Faslodex In Postmenopausal Women With HR Positive Breast Cancer
A Phase 2 study testing Arimidex and Faslodex in people with Breast Cancer, run by Mothaffar Rimawi at 1 site in United States.
Trial summary
Over the last 3 decades, a steady shift has occurred in the management of breast cancer. Because it was traditionally viewed as a local disease, many advocated the use of radical surgery to achieve maximum survival benefit. 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?
- Arimidex and Faslodex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to 5 Dec 2018
- Phase
- Phase 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
- All subjects must be female.
- Postmenopausal status, defined as any one of the following criteria:
- Documented history of bilateral oophorectomy.
- Age 60 years or more.
- Age 45 to 59 and satisfying one or more of the following criteria:
- Amenorrhea for at least 12 months and intact uterus.
Show all 19Show fewer
- Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) and estradiol concentration within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement.
- Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.
- Estrogen receptor and/or progesterone receptor positive disease.
- Patients must not have received any prior treatment for current or newly diagnosed breast cancer.
- Patients must have not received previous treatment with any of the study medications or similar drugs.
- No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years.
- WHO performance status of 0, 1, or 2.
- Adequate organ function defined as follows:
- Adequate renal function, defined by a serum creatinine within 3 times the upper limits of normal.
- Adequate liver function, defined by total bilirubin, AST, ALT, and alkaline phosphatase within 3 times the upper limits of normal.
- Adequate bone marrow function, defined as a WBC greater than 3.0 ml, PLT greater than 75,000/ul, Hb greater than 9 gm/l.
- Willing to undergo breast core biopsies as required by the study protocol. - Ability to understand and sign a written informed consent for participation in the trial.
- Life expectancy of at least 1 year.
Who cannot join
- Premenopausal status.
- Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ.
- Patients with brain metastasis.
- WHO performance status of 3 or 4.
- Is judged by the investigator, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial. - Concurrent treatment with estrogens or progestins. Patients must stop these drugs at least two weeks prior to study entry.
Show all 12Show fewer
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
- Platelet count less than 75,000.
- In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections.
- History of hypersensitivity to castor oil.
- Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded) - Patients with recurrent breast cancer.
- Patients with contralateral second primary breast cancers are eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Neoadjuvant Arimidex With or Without Faslodex in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Over the last 3 decades, a steady shift has occurred in the management of breast cancer. Because it was traditionally viewed as a local disease, many advocated the use of radical surgery to achieve maximum survival benefit. This view has been slowly replaced by a broader biologic view that recognizes the often systemic nature of breast cancer, even when it appears to be localized to the breast. Results from randomized clinical trials have demonstrated that less extensive surgery, or lumpectomy plus radiation therapy, are optimal for local management of early breast cancer. In addition to the less radical approach to surgical treatment of breast cancer, other randomized clinical trials have established the value of postoperative systemic therapy in improving overall survival by eradicating micrometastatic disease, the major cause of mortality from breast cancer. Despite the well-documented benefits of adjuvant systemic therapy, it is not effective in preventing death from breast cancer in all patients who are candidates for such treatment. The worth of such therapy can only be judged in retrospect upon disease relapse, a time when breast cancer is nearly always incurable. Currently, there are few reliable methods to predict the success or failure of a particular postoperative treatment modality, and better ways to predict and optimize outcome are needed.
Combination endocrine therapy: Using endocrine agents with different mechanisms of action together has the potential advantage of more effectively blocking ER signaling, thus improving the efficacy of such agents against breast cancer. In the past, attempts to combine endocrine agents for ER-positive breast cancer have had mixed results, depending on the setting and the patient population studied.
Endocrine agents without any agonist effect could potentially be used in combination with aromatase inhibitors, under the rationale that the combination would maximally blockade estrogen receptor signaling, thus potentially improving the antitumor effect. Fulvestrant (FASLODEX) is a pure estrogen antagonist with no known agonist effect; thus, it has the potential to provide additional benefit when combined with an aromatase inhibitor. This concept provides the rationale for using the combination of anastrazole and fulvestrant in this study.
Read the detailed description
Purpose and Objectives
The primary objective of this study is to determine if ER-targeted therapy, ARIMIDEX and FASLODEX, used in combination is superior to ARMIDEX alone in hormone receptor positive breast cancer.
Primary study objective 1. To determine the efficacy of primary breast cancer, as measured by decrease in proliferation (KI67), to the combination of ARIMIDEX, and FASLODEX at high dose
Secondary study objectives 1. To study molecular changes in response to treatment. 2. To correlate changes in Ki67 with clinical response 3. To determine the pathologic response rate. 4. To assess the tolerability and safety of the combination regimen.
This is a phase II randomized multi-center study. As indicated in the study design schema found in the protocol document attached to Section S, patients will be initially randomized to receive ARIMIDEX, or ARIMIDEX+FASLODEX (high dose) for 16 weeks (112 days). A computer-generated randomization scheme will be generated by the study statistician at the Breast Center, Baylor College of Medicine. A 1:1 randomization scheme using permuted blocks will be employed. Randomization will be centralized at the Breast Center, Baylor College of Medicine and accomplished via access to a secure web-based procedure that is currently being implemented in our other multi-center clinical trials. Enrollment, eligibility, and randomization information will be stored in an Oracle database on the Breast Center's Sun server and will be accessible only through secure web-based applications. Communication with the pharmacy will be handled by email which will contain only patient identification number and initials and by FAX or hardcopy. The hardcopy will be used by physicians to send to the pharmacy a signed computer-generated pharmacy order to legally dispense study drug.
Within 30 days prior to randomization subjects will sign the study consent form, and have a history and physical exam, including all concurrent medications. Blood will be drawn for CBC, platelets, serum chemistries, BUN, creatinine, and liver function tests. If necessary to determine menopausal status FSH, LH and serum estradiol will be obtained. An EKG, CXR PA and lateral will be performed and a bilateral mammogram and US of primary breast cancer will be done within 90 days of randomization. Subjects will then be randomized to receive either ARIMIDEX 1 mg po q day (Group A), or ARIMIDEX 1 mg po q day and FASLODEX 500 mg IM, day 1, day 14, day 28 and thereafter once every 28 days (Group B). Study medications will be dispensed within 60 days of randomization. On day 28, subjects will be evaluated for side effects and a second breast core biopsy will be obtained. Evaluation for tumor response and tolerability of the regimen will be evaluated every 28 days in outpatient clinic visits. ALL treatment will continue until day 112 when patients with a clinical response or stable disease will receive appropriate surgical resection. If the tumor is unresectable on day 112, a core needle biopsy will be done. The surgical specimen will be obtained for further molecular analysis. After surgery, patients will be off study and will receive additional breast cancer therapy at the discretion of their treating physician. Patients who develop progressive disease on protocol will be taken off study and offered alternative treatment. All patients will have a safety follow-up 1 month after the surgery (or the alternative core biopsy).
Treatment will be administered on outpatient basis. After the baseline breast biopsy, patients will be randomized to receive ARIMIDEX 1mg po q day (group A), or ARIMIDEX 1mg po q day with FASLODEX 500 mg day 1, day 14, day 28, and thereafter every 28 days (Group B). After 28 days a second biopsy will be obtained in all patients. All patients will continue on the same randomized treatment for the total duration of the study of 112 days till the day before surgery. No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.
Study Visit Procedures: Pre-Study Procedures will include the following: informed consent, breast biopsy, demographics, medical history, concurrent medication list, physical exam, blood draw, bidimensional tumor measurement, bilateral mammogram, primary breast ultrasound and chest x-ray.
Day 1 procedures will include the following: study drug administration, clinic visit.
Day 14 procedures will include the following (group B only) study drug injection and clinic visit.
Day 28 procedures will include the following (group B only) study drug injection. Both group A and B, breast biopsy, concurrent medication list, physical exam, blood draw, clinic visit, adverse events evaluation, bidimensional tumor measurement.
Day 56 procedures will include the following (group B only) study drug injection. Both group A and B, concurrent medication list, physical exam, blood draw, adverse events evaluation, clinic visit and bidimensional tumor measurement.
Day 84 procedures include (group B only) study drug injection. Both group A and B, concurrent medication list, physical exam, blood draw, adverse event evaluation, clinic visit and bidimensional tumor measurement.
Day 112 procedures include study drug administration, concurrent medication list, physical exam, blood draw, adverse events evaluation, bidimensional tumor measurement, bilateral mammogram, primary breast ultrasound and tumor resection.
Day 140 procedures include blood draw, clinic visit and safety evaluation for adverse events.
Duration of Therapy In the absence of treatment delays due to adverse events, treatment will continue for 4 months or until one of the following criteria applies: Disease progression, Intercurrent illness that prevents further administration of treatment, Unacceptable adverse events(s), Patient decides to withdraw from the study, or General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
This protocol will close 6 months after the last patient is enrolled. Patients will receive study medications from day 0 until day 111, which is the day before their planned surgery. On day 140, patients will have a safety follow up visit and to determine the need for further treatment after surgery.
Breast Core Biopsy All subjects will have a breast tumor core biopsy at the beginning of the study, and a second biopsy after 2 weeks. Core needle biopsies are planned because they will provide sufficient histologically evaluable tissue for the assays proposed in this study.
- Conditions
- Breast Cancer
- Being tested
- Arimidex, Faslodex
- Keywords
- Breast Cancer, HORMONE RECEPTOR POSITIVE BREAST CANCER
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArimidexDrug
Also called Anastrozole
Aromatase inhibitors
FaslodexDrug
Also called Fulvestrant
Hormone Receptor
| Study group | Role | What they receive |
|---|---|---|
| ARM A / Arimidex with Faslodex | Active comparator | Arimidex with Faslodex in postmenopausal women Receives: Drug: Arimidex; Drug: Faslodex |
| ARM B Arimidex without Faslodex | Active comparator | Arimidex without Faslodex in postmenopausal women. Receives: Drug: Arimidex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples
The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.
Measured: baseline (pre) to day 28 (post)
Secondary outcomes (2)
Clinical Response
Measurable lesions were examined at baseline to treatment completion.Clinical Response was defined by Solid Tumor Response Criteria (RECIST).
Measured: 1 Year
Pathologic Complete Response
Pathologic response was defined as no residual invasive tumor on histopathological analysis in the breast primary. Patients were assessed according to the Chevallier classification of pathologic response.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionOct 2016
- Study completion5 Dec 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mothaffar Rimawi
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Mothaffar Rimawi, Baylor Breast Care Center
- Investigators
- Mothaffar Rimawi, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570323
- Sponsor's protocol ID
- H 20431
- Other IDs
- IRUSFULV0060
- Acronym
- PACT001
- Status last verified
- Jul 2020
- First submitted
- 6 Dec 2007
- Last updated
- 28 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Neoadjuvant Arimidex With or Without Faslodex in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00570323
- Acronym / sponsor ID
- PACT001 / H 20431
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, HORMONE RECEPTOR POSITIVE BREAST CANCER
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mothaffar RimawiUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2007 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 10 Dec 2007 (estimated)
- Results
- Posted 4 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the last 3 decades, a steady shift has occurred in the management of breast cancer. Because it was traditionally viewed as a local disease, many advocated the use of radical surgery to achieve maximum survival benefit. This view has been slowly replaced by a broader biologic view that recognizes the often systemic nature of breast cancer, even when it appears to be localized to the breast. Results from randomized clinical trials have demonstrated that less extensive surgery, or lumpectomy plus radiation therapy, are optimal for local management of early breast cancer. In addition to the less radical approach to surgical treatment of breast cancer, other randomized clinical trials have established the value of postoperative systemic therapy in improving overall survival by eradicating micrometastatic disease, the major cause of mortality from breast cancer. Despite the well-documented benefits of adjuvant systemic therapy, it is not effective in preventing death from breast cancer in all patients who are candidates for such treatment. The worth of such therapy can only be judged in retrospect upon disease relapse, a time when breast cancer is nearly always incurable. Currently, there are few reliable methods to predict the success or failure of a particular postoperative treatment modality, and better ways to predict and optimize outcome are needed.
Combination endocrine therapy: Using endocrine agents with different mechanisms of action together has the potential advantage of more effectively blocking ER signaling, thus improving the efficacy of such agents against breast cancer. In the past, attempts to combine endocrine agents for ER-positive breast cancer have had mixed results, depending on the setting and the patient population studied.
Endocrine agents without any agonist effect could potentially be used in combination with aromatase inhibitors, under the rationale that the combination would maximally blockade estrogen receptor signaling, thus potentially improving the antitumor effect. Fulvestrant (FASLODEX) is a pure estrogen antagonist with no known agonist effect; thus, it has the potential to provide additional benefit when combined with an aromatase inhibitor. This concept provides the rationale for using the combination of anastrazole and fulvestrant in this study.
Detailed description
Purpose and Objectives
The primary objective of this study is to determine if ER-targeted therapy, ARIMIDEX and FASLODEX, used in combination is superior to ARMIDEX alone in hormone receptor positive breast cancer.
Primary study objective 1. To determine the efficacy of primary breast cancer, as measured by decrease in proliferation (KI67), to the combination of ARIMIDEX, and FASLODEX at high dose
Secondary study objectives 1. To study molecular changes in response to treatment. 2. To correlate changes in Ki67 with clinical response 3. To determine the pathologic response rate. 4. To assess the tolerability and safety of the combination regimen.
This is a phase II randomized multi-center study. As indicated in the study design schema found in the protocol document attached to Section S, patients will be initially randomized to receive ARIMIDEX, or ARIMIDEX+FASLODEX (high dose) for 16 weeks (112 days). A computer-generated randomization scheme will be generated by the study statistician at the Breast Center, Baylor College of Medicine. A 1:1 randomization scheme using permuted blocks will be employed. Randomization will be centralized at the Breast Center, Baylor College of Medicine and accomplished via access to a secure web-based procedure that is currently being implemented in our other multi-center clinical trials. Enrollment, eligibility, and randomization information will be stored in an Oracle database on the Breast Center's Sun server and will be accessible only through secure web-based applications. Communication with the pharmacy will be handled by email which will contain only patient identification number and initials and by FAX or hardcopy. The hardcopy will be used by physicians to send to the pharmacy a signed computer-generated pharmacy order to legally dispense study drug.
Within 30 days prior to randomization subjects will sign the study consent form, and have a history and physical exam, including all concurrent medications. Blood will be drawn for CBC, platelets, serum chemistries, BUN, creatinine, and liver function tests. If necessary to determine menopausal status FSH, LH and serum estradiol will be obtained. An EKG, CXR PA and lateral will be performed and a bilateral mammogram and US of primary breast cancer will be done within 90 days of randomization. Subjects will then be randomized to receive either ARIMIDEX 1 mg po q day (Group A), or ARIMIDEX 1 mg po q day and FASLODEX 500 mg IM, day 1, day 14, day 28 and thereafter once every 28 days (Group B). Study medications will be dispensed within 60 days of randomization. On day 28, subjects will be evaluated for side effects and a second breast core biopsy will be obtained. Evaluation for tumor response and tolerability of the regimen will be evaluated every 28 days in outpatient clinic visits. ALL treatment will continue until day 112 when patients with a clinical response or stable disease will receive appropriate surgical resection. If the tumor is unresectable on day 112, a core needle biopsy will be done. The surgical specimen will be obtained for further molecular analysis. After surgery, patients will be off study and will receive additional breast cancer therapy at the discretion of their treating physician. Patients who develop progressive disease on protocol will be taken off study and offered alternative treatment. All patients will have a safety follow-up 1 month after the surgery (or the alternative core biopsy).
Treatment will be administered on outpatient basis. After the baseline breast biopsy, patients will be randomized to receive ARIMIDEX 1mg po q day (group A), or ARIMIDEX 1mg po q day with FASLODEX 500 mg day 1, day 14, day 28, and thereafter every 28 days (Group B). After 28 days a second biopsy will be obtained in all patients. All patients will continue on the same randomized treatment for the total duration of the study of 112 days till the day before surgery. No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.
Study Visit Procedures: Pre-Study Procedures will include the following: informed consent, breast biopsy, demographics, medical history, concurrent medication list, physical exam, blood draw, bidimensional tumor measurement, bilateral mammogram, primary breast ultrasound and chest x-ray.
Day 1 procedures will include the following: study drug administration, clinic visit.
Day 14 procedures will include the following (group B only) study drug injection and clinic visit.
Day 28 procedures will include the following (group B only) study drug injection. Both group A and B, breast biopsy, concurrent medication list, physical exam, blood draw, clinic visit, adverse events evaluation, bidimensional tumor measurement.
Day 56 procedures will include the following (group B only) study drug injection. Both group A and B, concurrent medication list, physical exam, blood draw, adverse events evaluation, clinic visit and bidimensional tumor measurement.
Day 84 procedures include (group B only) study drug injection. Both group A and B, concurrent medication list, physical exam, blood draw, adverse event evaluation, clinic visit and bidimensional tumor measurement.
Day 112 procedures include study drug administration, concurrent medication list, physical exam, blood draw, adverse events evaluation, bidimensional tumor measurement, bilateral mammogram, primary breast ultrasound and tumor resection.
Day 140 procedures include blood draw, clinic visit and safety evaluation for adverse events.
Duration of Therapy In the absence of treatment delays due to adverse events, treatment will continue for 4 months or until one of the following criteria applies: Disease progression, Intercurrent illness that prevents further administration of treatment, Unacceptable adverse events(s), Patient decides to withdraw from the study, or General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
This protocol will close 6 months after the last patient is enrolled. Patients will receive study medications from day 0 until day 111, which is the day before their planned surgery. On day 140, patients will have a safety follow up visit and to determine the need for further treatment after surgery.
Breast Core Biopsy All subjects will have a breast tumor core biopsy at the beginning of the study, and a second biopsy after 2 weeks. Core needle biopsies are planned because they will provide sufficient histologically evaluable tissue for the assays proposed in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A / Arimidex with Faslodex | Active comparator | Drug: Arimidex, Drug: FaslodexArimidex with Faslodex in postmenopausal women |
| ARM B Arimidex without Faslodex | Active comparator | Drug: ArimidexArimidex without Faslodex in postmenopausal women. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- All subjects must be female.
- Postmenopausal status, defined as any one of the following criteria:
- Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.
- Estrogen receptor and/or progesterone receptor positive disease.
- Patients must not have received any prior treatment for current or newly diagnosed breast cancer.
Key exclusion criteria (12 listed)
- Premenopausal status.
- Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ.
- Patients with brain metastasis.
- WHO performance status of 3 or 4.
- Is judged by the investigator, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| ArimidexAlso: AnastrozoleAromatase inhibitors | Drug | ARM A / Arimidex with Faslodex, ARM B Arimidex without Faslodex |
| FaslodexAlso: FulvestrantHormone Receptor | Drug | ARM A / Arimidex with Faslodex |
Primary outcome
Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples
Time frame: baseline (pre) to day 28 (post)
The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.
2 secondary outcomes
Clinical Response
Time frame: 1 Year
Pathologic Complete Response
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mothaffar Rimawi, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arimidex and Faslodex in people with Breast Cancer, run by Mothaffar Rimawi 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 19 inclusion and 12 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 Jul 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.
What does this phase mean?
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 4 Mar 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?
Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples (time frame: baseline (pre) to day 28 (post)). 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 Jul 2020.