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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Depression

Edema limbs

Creatinine increased

Generalized muscle weakness

Fall

Back pain

Arthralgia

Alanine aminotransferase

Acute kidney injury

CPK increased

Alkaline phosphatase increased

Dehydration

Bloating

Confusion

Hot flashes

Productive cough

Gastroesophageal reflux disease

General disorders and administration site conditions - Other, specify: Chills

Hoarseness

Watering eyes

Wheezing

Laryngeal inflammation

Non-cardiac chest pain

Upper respiratory infection

Vertigo

Muscle weakness lower limb

Musculoskeletal and connective tissue disorder - Other, specify: Body aches

Photosensitivity

Pruritus

Nasal congestion

Tremor

Bone pain

Aspartate aminotransferase

100%

80%

60%

40%

20%

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Goserelin

2008

Completed Phase 3

~3930

Tumor biopsy

2014

Completed Phase 2