Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib

NCT02913430 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: HCC 16-015
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To assess longitudinal changes in allele frequency of ESR1 mutation in plasma in patients treated with Fulvestrant plus palbociclib compared to tamoxifen plus palbociclib

Conditions

Metastatic Breast Cancer

Keywords

ESR1 mutation

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  The duration of time from time of randomization to time of progression or death, whichever occurs first. Disease progression (PD) as defined by RECIST v1.1: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The progression of non-target lesions or the appearance of one or more new lesions is also considered progression. PFS for a subject without an event will be censored on the date of last tumor assessment. If an interval of 6 months passes without a tumor assessment, PFS will be censored at the time of the earlier tumor assessment, even if an event (progressive disease or death) is later observed.

  Up to 3 years and 351 days

Secondary Outcomes (4)

• Best Overall Response (BOR)

  Up to 5 years

• 6-Month Clinical Benefit Rate (CBR)

  Up to 6 months

• Clinical Benefit Rate (CBR)

  Up to 5 years

• Overall Survival (OS)

  Up to 5 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

fulvestrant administered 500mg IM Q28 days plus palbociclib125mg/day PO on a 21 days on/7 days off schedule

Drug: Fulvestrant; Drug: Palbociclib

Arm B

ACTIVE COMPARATOR

Tamoxifen is administered orally, at a dose of20mg PO Qdaily plus palbociclib125mg/day PO on a 21 days on/7 days off schedule

Drug: Tamoxifen; Drug: Palbociclib

Interventions

Fulvestrant DRUG

500mg IM Q28 days

Arm A

Tamoxifen DRUG

20mg PO Qdaily

Arm B

Palbociclib DRUG

Tamoxifen or Fulvestrant plus palbociclib125mg/day PO on a 21 days on/7 days off schedule

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Prior therapy with fulvestrant
• Prior therapy with tamoxifen in the metastatic setting
• More than 3 prior lines of endocrine therapy in the metastatic setting
• More than one prior line of chemotherapy in the metastatic setting
• Washout of 2 weeks is required for aromatase inhibitors; washout of 4 weeks is required for, everolimus or other biological agents with the exception of Palbociclib.
• Patients must not be receiving any other investigational agent.
• Patients with symptomatic, untreated CNS metastases are not eligible.
• Patients may not have significant concurrent illness, infection, pregnancy or lactation
• Patients must not have a different active malignancy, except for skin basal cell carcinoma, skin squamous cell carcinoma and cervical intraepithelial neoplasia.

Sponsors & Collaborators

• Shannon Puhalla: lead

Study Sites (1)

Magee-Womens Hospital UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; Tamoxifen; palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Barbara Stadterman, MPH, MSCR
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• Shannon Puhalla, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 23, 2016
• Study Start: April 24, 2018
• Primary Completion: April 12, 2022
• Study Completion: April 30, 2024
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)