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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
Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2 negative (0 or 1+ by IHC or FISH negative for amplification) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Note: Patients with invasive ER+ (Allred Score of 6-8) HER2- breast cancer or DCIS in the contralateral breast the patient are eligible
Must not have
History of any lymphoproliferative disorder
History of active malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I can take care of myself and am up and about more than half of my waking hours.
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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 has a PIK3CA mutation.
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I had surgery on my breast and underarm area to remove cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a condition where my lymphocytes grow abnormally.
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I have a history of cancer.
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I am currently on blood thinners.
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I can swallow pills without difficulty.
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I do not have any severe illnesses that could interfere with the study.
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My cancer is inflammatory.
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My cancer has spread to other parts of my body.
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I am not using, nor do I need, strong medication that affects drug metabolism.
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I am HIV-positive and on antiretroviral therapy.
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I have been treated with a Cdk4 inhibitor before.
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I have had a biopsy of my breast cancer or a sentinel lymph node biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Neoplasms
Clinical Response Rate
Distant Recurrence Rate
+11 more

Side effects data

From 2015 Phase 2 trial • 19 Patients • NCT01291017
47%
Fatigue
37%
Nausea
32%
Vomiting
32%
Mucositis oral
26%
Neutrophil count decreased
26%
Constipation
21%
Anemia
21%
Anorexia
21%
Platelet count decreased
16%
Abdominal pain
16%
Dizziness
16%
Cough
11%
Dysgeusia
11%
Anxiety
11%
Diarrhea
11%
Dyspnea
11%
Epistaxis
11%
Psychiatric disorders - Other, specify: Mood changes
11%
Sore throat
11%
Musculoskeletal and connective tissue disorder - Other, specify: Muscle cramps
11%
Headache
11%
Laryngeal hemorrhage
11%
Rash maculo-papular
11%
White blood cell decreased
11%
Pain
11%
Blurred vision
5%
Depression
5%
Edema limbs
5%
Creatinine increased
5%
Generalized muscle weakness
5%
Fall
5%
Back pain
5%
Arthralgia
5%
Alanine aminotransferase
5%
Acute kidney injury
5%
CPK increased
5%
Alkaline phosphatase increased
5%
Dehydration
5%
Bloating
5%
Confusion
5%
Hot flashes
5%
Productive cough
5%
Gastroesophageal reflux disease
5%
General disorders and administration site conditions - Other, specify: Chills
5%
Hoarseness
5%
Watering eyes
5%
Wheezing
5%
Laryngeal inflammation
5%
Non-cardiac chest pain
5%
Upper respiratory infection
5%
Vertigo
5%
Muscle weakness lower limb
5%
Musculoskeletal and connective tissue disorder - Other, specify: Body aches
5%
Photosensitivity
5%
Pruritus
5%
Nasal congestion
5%
Tremor
5%
Bone pain
5%
Aspartate aminotransferase
100%
80%
60%
40%
20%
0%
Study treatment Arm
PD0332991

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~4270
Tumor biopsy
2014
Completed Phase 2
~280
PD0332991
2011
Completed Phase 2
~210
Anastrozole
2016
Completed Phase 4
~5550

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,984 Previous Clinical Trials
2,291,636 Total Patients Enrolled
49 Trials studying Breast Cancer
5,231 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,642 Previous Clinical Trials
17,742,979 Total Patients Enrolled
115 Trials studying Breast Cancer
41,409 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

Anastrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01723774 — Phase 2
Breast Cancer Research Study Groups: Arm 2: PIK3CA Mutant Type Cohort, Arm 1: PIK3CA Wild Type Cohort, Arm 3: Endocrine Resistant Cohort
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT01723774 — Phase 2
Anastrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01723774 — Phase 2
~7 spots leftby Oct 2025
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