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Hormone Therapy
PD0332991 + Anastrozole for Breast Cancer
Phase 2
Waitlist Available
Led By Cynthia Ma, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0, 1 or 2
Premenopausal women, serum estradiol level in postmenopausal range ≤ 7 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can help treat early stage breast cancer.
Who is the study for?
This trial is for premenopausal women over 18 with early-stage ER+ HER2- breast cancer, who have not received prior treatment for this cancer. They must be willing to use contraception and have a life expectancy over 4 months. Participants need adequate organ function and no history of certain cancers or conditions that would interfere with the study.Check my eligibility
What is being tested?
The trial tests if PD0332991 combined with anastrozole improves response rates in breast cancer compared to aromatase inhibitors alone. It also checks if fewer patients have high levels of Ki67, indicating cell proliferation, after treatment. The study includes surgery as standard care and tumor biopsies.See study design
What are the potential side effects?
Potential side effects include issues related to organ inflammation, reactions specific to drug components (allergic), gastrointestinal disturbances due to oral medication intake, possible heart rhythm problems (QT interval changes), and general risks associated with taking hormonal therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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My last blood test shows I am in menopause.
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My breast cancer is ER+ and HER2-, aiming for surgery to remove the tumor.
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I am a woman aged 18 or older.
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My blood tests show normal organ function and blood cell counts.
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My tumor is growing quickly and is resistant to hormone therapy.
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My tumor has a PIK3CA mutation.
Select...
It's been over 4 weeks since I finished my last chemotherapy and radiation.
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I had surgery on my breast and underarm area to remove cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 (Endocrine Resistant Cohort Only)
Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 (PIK3CA Wild Type Cohort Only)
Secondary outcome measures
Neoplasms
Clinical Response Rate
Distant Recurrence Rate
+13 moreSide effects data
From 2015 Phase 2 trial • 19 Patients • NCT0129101747%
Fatigue
37%
Nausea
32%
Mucositis oral
32%
Vomiting
26%
Neutrophil count decreased
26%
Constipation
21%
Anemia
21%
Anorexia
21%
Platelet count decreased
16%
Abdominal pain
16%
Dizziness
16%
Cough
11%
Laryngeal hemorrhage
11%
Anxiety
11%
Dysgeusia
11%
Dyspnea
11%
Epistaxis
11%
Musculoskeletal and connective tissue disorder - Other, specify: Muscle cramps
11%
Psychiatric disorders - Other, specify: Mood changes
11%
Rash maculo-papular
11%
Sore throat
11%
White blood cell decreased
11%
Diarrhea
11%
Headache
11%
Pain
11%
Blurred vision
5%
Vertigo
5%
Dehydration
5%
Arthralgia
5%
Generalized muscle weakness
5%
Alanine aminotransferase
5%
Creatinine increased
5%
CPK increased
5%
Acute kidney injury
5%
Fall
5%
Photosensitivity
5%
Alkaline phosphatase increased
5%
Bloating
5%
Hoarseness
5%
Back pain
5%
Non-cardiac chest pain
5%
Tremor
5%
Hot flashes
5%
Confusion
5%
Edema limbs
5%
Gastroesophageal reflux disease
5%
Laryngeal inflammation
5%
Muscle weakness lower limb
5%
Musculoskeletal and connective tissue disorder - Other, specify: Body aches
5%
Nasal congestion
5%
Productive cough
5%
Pruritus
5%
Upper respiratory infection
5%
Watering eyes
5%
Wheezing
5%
Depression
5%
General disorders and administration site conditions - Other, specify: Chills
5%
Bone pain
5%
Aspartate aminotransferase
100%
80%
60%
40%
20%
0%
Study treatment Arm
PD0332991
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm 3: Endocrine Resistant CohortExperimental Treatment5 Interventions
Tumor biopsy for testing/research at baseline and Cycle 1 Day 15
Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)
Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.
Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned.
Group II: Arm 2: PIK3CA Mutant Type CohortExperimental Treatment5 Interventions
Tumor biopsy for testing/research at baseline and Cycle 1 Day 15
Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.
Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)
Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.
Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned.
Group III: Arm 1: PIK3CA Wild Type CohortExperimental Treatment5 Interventions
Tumor biopsy for testing/research at baseline and Cycle 1 Day 15
Cycle 0 is 28 days of anastrozole PO daily and, if premenopausal, goserelin SC every 28 days.
Cycles 1-5: PD 0332991 combined with anastrozole (and goserelin if premenopausal) is to be (4) 28-day cycles followed by a 5th cycle of 10-12 days duration consisting of daily PD 0332991 and anastrozole (last dose day before surgery)
Standard surgery will be performed per institutional standards 2-4 weeks following the completion of Cycle 4 in those who did not receive Cycle 5. In patients who receive Cycle 5, surgery occurs on Day 11, 12, or 13 of Cycle 5.
Patients who derived benefit from the therapy have the option of taking PD 0332991 in combination with endocrine therapy for 23 cycles after surgery and adjuvant chemotherapy and radiation if indicated. It should be re-started at least 4 weeks after the completion of chemotherapy and radiation therapy if these treatments were planned.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Goserelin
2008
Completed Phase 3
~7100
Tumor biopsy
2014
Completed Phase 2
~240
PD0332991
2011
Completed Phase 2
~210
Anastrozole
2019
Completed Phase 4
~10090
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,625 Total Patients Enrolled
47 Trials studying Breast Cancer
5,168 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,789 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Cynthia Ma, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
4 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.I haven't had cancer in the last 5 years, except for skin cancer.You are taking any experimental medications.Your heart's electrical activity takes too long to reset.I haven't had a heart attack, severe chest pain, heart surgery, stroke, mini-stroke, or a serious blood clot in the last 6 months.I am currently on blood thinners.I can swallow pills without difficulty.I can take care of myself and am up and about more than half of my waking hours.My last blood test shows I am in menopause.I have had treatments like surgery, radiation, or chemotherapy for my cancer before joining this study.I do not have any severe illnesses that could interfere with the study.My cancer is inflammatory.My cancer has spread to other parts of my body.My breast cancer is ER+ and HER2-, aiming for surgery to remove the tumor.I am a woman aged 18 or older.My blood tests show normal organ function and blood cell counts.I am not using, nor do I need, strong medication that affects drug metabolism.My tumor is growing quickly and is resistant to hormone therapy.I am HIV-positive and on antiretroviral therapy.I have been treated with a Cdk4 inhibitor before.I have had a biopsy of my breast cancer or a sentinel lymph node biopsy.You are expected to live for more than 4 months.My tumor has a PIK3CA mutation.It's been over 4 weeks since I finished my last chemotherapy and radiation.You have had allergic reactions to drugs similar to PD 0332991 or other drugs being used in the study.I had surgery on my breast and underarm area to remove cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: PIK3CA Mutant Type Cohort
- Group 2: Arm 1: PIK3CA Wild Type Cohort
- Group 3: Arm 3: Endocrine Resistant Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many different places are participating in this research project?
"Mayo Clinic - Rochester (Rochester, Minnesota), Washington University School of Medicine (Saint Louis, Missouri), and Mayo Clinic - Scottsdale (Scottsdale, Arizona) are a few of the many places where patients can enroll in this clinical trial."
Answered by AI
Are people with this medical condition able to sign up for the clinical trial at this time?
"The clinical trial isn't currently recruiting patients. The original posting was on April 10th, 2013, and the most recent edit was on September 22nd, 2022. However, there are 2624 other trials actively searching for participants right now."
Answered by AI
To your knowledge, has anything like this been tried before?
"PD0332991 has been under investigation since the year 2000. The first clinical trial was funded by AstraZeneca and took place in 2000 with a pool of 600 participants. After this initial study, PD0332991 received approval to enter Phase 3 drug trials. As of now, there are 252 active studies involving PD0332991 being conducted across 2046 cities and 68 countries worldwide."
Answered by AI
What are some of the potential risks associated with PD0332991?
"As this is a phase 2 trial, there is some data to support the safety of PD0332991; however, as there is not yet any evidence for efficacy, it received a score of 2."
Answered by AI
Could you please provide more information on other research projects that have studied PD0332991?
"PD0332991 was first trialled in 2000 at the Centre de Recherche Clinique du CHUS. To date, there have been a total of 268 clinical trials completed. Currently, 252 studies are actively recruiting patients, with many of these based out of Rochester, Minnesota."
Answered by AI
What indications has PD0332991 been shown to be effective for?
"PD0332991 is not only used to breast cancer, but also for other conditions like endometrial thinning, stage t2b carcinoma of the prostate, and as a radiation sensitizer."
Answered by AI
How many people are being asked to participate in this experiment?
"Unfortunately, this study has already ceased recruiting patients. The listing was first created on April 10th, 2013 and last updated on September 22nd, 2022. However, there are 2372 trials actively recruiting breast cancer patients and 252 studies still looking for participants that match the PD0332991 criteria."
Answered by AI
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