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PD0332991 in combination with weekly paclitaxel at a fixed dose of 80 mg/m2

PD0332991

This study is a phase I, single arm, open-label trial of PD0332991 in combination with Paclitaxel in patients with Rb-expressing metastatic breast cancer. Up to 20 patients are anticipated to be enrolled to reach the Maximum Tolerated Dose (MTD) of PD0332991 in combination with Paclitaxel. Once the MTD is established, an additional expanded cohort of 10 patients will be enrolled at that dose to establish the Recommended Phase 2 Dose (RP2D), obtain additional safety data and perform exploratory biomarker studies.

This study is a phase I, single arm, open-label trial of PD0332991 in combination with paclitaxel in patients with Rb-expressing metastatic breast cancer. Patients will be treated as shown in the schema below. Up to 20 patients are anticipated to be enrolled to reach the MTD of PD0332991 in combination with Paclitaxel. Once the MTD is established, an additional expanded cohort of 10 patients will be enrolled at that dose to establish the RP2D, obtain additional safety data and perform exploratory biomarker studies. The primary endpoint will be assessed after one cycle of therapy. Patients will remain on study until dose limiting toxicity, disease progression or physician/patient discretion. Safety assessment will continue for the duration of patient participation.

PD0332991/Paclitaxel in Advanced Breast Cancer

A Phase 1 Trial of PD0332991 and Paclitaxel in Patients With Rb-Expressing Advanced Breast Cancer

To determine the maximally-tolerated dose and safety of PD0332991 in combination with a fixed, weekly dose of Paclitaxel of 80 mg/m2 and to characterize the safety of the combination during the first three cycles of therapy.

To explore the activity of the combination at the MTD in an expanded cohort of breast cancer patients.

To explore the relationship between selected biomarkers and efficacy, tolerability and safety outcomes

Abramson Cancer Center at Penn Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PD0332991/Paclitaxel in Advanced Breast Cancer	NCT01320592	Breast Cancer	PD0332991 Paclitaxel	18 Years -	Abramson Cancer Center at Penn Medicine
PD0332991/Paclitaxel in Advanced Breast Cancer	NCT01320592	Breast Cancer	PD0332991 Paclitaxel	18 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for tumor must express retinoblastoma (rb) protein, defined as