AzTrials
AzTrials

Breast CancerPhase 2NCT01437566

Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy

A Phase 2 study testing Fulvestrant, GDC-0941 and GDC-0980 in people with Breast Cancer, run by Genentech, Inc. at 130 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Fulvestrant, GDC-0941 and GDC-0980
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
318 participants
Where
130 sitesin 23 countries
Study dates
Oct 2011to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • As per national or local treatment guidelines, endocrine therapy (i.e., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not necessary for participants, at time of entry into the study.
  • Part I: Postmenopausal women with locally ABC or MBC whose disease relapsed during treatment with (or within 6 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting.
  • Part II: Postmenopausal women with locally ABC or MBC whose disease has progressed during or after treatment with an AI. Participants who discontinued the AI for toxicity rather than completion of regimen or for disease progression are not eligible
  • Estrogen receptor (ER)-positive disease and human epidermal receptor 2 (HER2)-negative disease
  • Participants must have measurable disease by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 or bone-only disease with radiologic scans
  • Adequate hematologic and end-organ function

Who cannot join

  • Prior treatment with fulvestrant, phosphoinositide 3-kinase (PI3K) inhibitor, or mechanistic target of rapamycin (mTOR) inhibitor for ABC or MBC
  • Prior anti-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
  • Prior treatment with greater than (>) one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on > two endocrine therapies for MBC
  • Participants requiring anti-hyperglycemic therapy
  • Clinically significant cardiac or pulmonary dysfunction
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
Show all 15Show fewer
  • Clinically significant history of liver disease
  • Active uncontrolled autoimmune disease or active inflammatory disease
  • Immunocompromised status
  • Need for current chronic corticosteroid therapy
  • Pregnancy, lactation, or breastfeeding
  • Current severe, uncontrolled systemic disease
  • Symptomatic hypercalcemia
  • Known untreated or active central nervous system (CNS) metastases
  • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or patients who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence

Trial locations and contacts

130 sites in 23 countries.

130 sites in 23 countries

United States41 sites

  • Study site

    Basking Ridge, New Jersey, 07920

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boca Raton, Florida, 33428

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Commack, New York, 11725

  • Study site

    Dallas, Texas, 75246

  • Study site

    Fort Myers, Florida, 33916

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Hayward, California, 94545

  • Study site

    Houston, Texas, 77030-4095

  • Study site

    Houston, Texas, 77030

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Joliet, Illinois, 60435

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New York, New York, 10065

  • Study site

    Oakland, California, 94611

  • Study site

    Peoria, Illinois, 61615

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Richmond, Virginia, 23226

  • Study site

    Rockville Centre, New York, 11570

  • Study site

    Roseville, California, 95661

  • Study site

    Sacramento, California, 95825

  • Study site

    San Francisco, California, 94115

  • Study site

    San Jose, California, 95119

  • Study site

    Santa Clara, California, 95051

  • Study site

    Sleepy Hollow, New York, 10591

  • Study site

    South San Francisco, California, 94080

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St. Petersburg, Florida, 33705

  • Study site

    Tyler, Texas, 75702

  • Study site

    Vallejo, California, 94589

  • Study site

    Walnut Creek, California, 94596

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    Wichita, Kansas, 67214-3728

Other trials in United States

Germany9 sites

  • Study site

    Berlin, 13125

  • Study site

    Düsseldorf, 40225

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Freiburg im Breisgau, 79110

  • Study site

    Hamburg, 20246

  • Study site

    München, 80336

  • Study site

    München, 81377

  • Study site

    München, 81675

  • Study site

    Trier, 54290

Other trials in Germany

Israel9 sites

  • Study site

    Beersheba, 8410101

  • Study site

    Holon, 58100

  • Study site

    Jerusalem, 91120

  • Study site

    Jerusalem, 9372212

  • Study site

    Kfar Saba, 4428164

  • Study site

    Rehovot, 7610001

  • Study site

    Tel Aviv, 6423906

  • Study site

    Tel HaShomer, 52621

  • Study site

    Tsrifin, 70300

Other trials in Israel

Italy9 sites

  • Study site

    Meldola, Emilia-Romagna, 47014

  • Study site

    Milan, Lombardy, 20121

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20141

  • Study site

    Monza, Lombardy, 20900

  • Study site

    Naples, Campania, 80131

  • Study site

    Pisa, Tuscany, 56100

  • Study site

    Prato, Tuscany, 59100

  • Study site

    Terni, Umbria, 05100

Other trials in Italy

Australia7 sites

  • Study site

    Bedford Park, South Australia, 5042

  • Study site

    Frankston, Victoria, 3199

  • Study site

    Kogarah, New South Wales, 2217

  • Study site

    Parkville, Victoria, 3050

  • Study site

    South Brisbane, Queensland, 4101

  • Study site

    Wahroonga, New South Wales, 2076

  • Study site

    Woodville, South Australia, 5011

Other trials in Australia

Denmark6 sites

  • Study site

    Aarhus, 8000

  • Study site

    Herlev, 2730

  • Study site

    København Ø, 2100

  • Study site

    Odense, 5000

  • Study site

    Roskilde, 4000

  • Study site

    Vejle, 7100

Other trials in Denmark

Belgium5 sites

  • Study site

    Brussels, 1000

  • Study site

    Brussels, 1070

  • Study site

    Edegem, 2650

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

Other trials in Belgium

Malaysia5 sites

  • Study site

    George Town, 10050

  • Study site

    George Town, 10400

  • Study site

    Kuala Lumpur, 56000

  • Study site

    Kuala Lumpur, 59100

  • Study site

    Tanjung Bungah, 11200

Other trials in Malaysia

United Kingdom5 sites

  • Study site

    Brighton, BN1 9PX

  • Study site

    Cardiff, CF14 2TL

  • Study site

    London, SW3 6JJ

  • Study site

    London, W1G 6AD

  • Study site

    Stoke-on-Trent, ST4 7LN

Other trials in United Kingdom

Chile4 sites

  • Study site

    Santiago, 7630370

  • Study site

    Temuco, 4810469

  • Study site

    Valparaíso, 2341391

  • Study site

    Viña del Mar, 2540364

Other trials in Chile

Russia4 sites

  • Study site

    Chelyabinsk, 454087

  • Study site

    Kazan', 420029

  • Study site

    Moscow, 115478

  • Study site

    Voronezh, 394000

Other trials in Russia

Spain4 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Lleida, Lerida, 25198

  • Study site

    Valencia, Valencia, 46015

  • Study site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Canada3 sites

  • Study site

    Montreal, Quebec, H3G 1A4

  • Study site

    Québec, Quebec, G1R 2J6

  • Study site

    Saskatoon, Saskatchewan, S7N 4H4

Other trials in Canada

Czechia3 sites

  • Study site

    Brno, 656 53

  • Study site

    Olomouc, 775 20

  • Study site

    Prague, 128 08

Other trials in Czechia

New Zealand3 sites

  • Study site

    Christchurch

  • Study site

    Hamilton, 3240

  • Study site

    Wellington, 0621

Other trials in New Zealand

Peru3 sites

  • Study site

    Lima, 11

  • Study site

    Lima, 34

  • Study site

    Lima, Lima 27

Other trials in Peru

Argentina2 sites

  • Study site

    Buenos Aires, 1025

  • Study site

    Santa Fe, 03000

Other trials in Argentina

Hong Kong2 sites

  • Study site

    Hong Kong, 852

  • Study site

    Pokfulam

Other trials in Hong Kong

Thailand2 sites

  • Study site

    Patumwan, 10330

  • Study site

    Songkhla, 90110

Other trials in Thailand

France1 site

  • Study site

    Paris, 75231

Other trials in France

Mexico1 site

  • Study site

    León, 37000

Other trials in Mexico

Singapore1 site

  • Study site

    Singapore, 119074

Other trials in Singapore

South Korea1 site

  • Study site

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Phase II, Double-Blind, Placebo Controlled, Randomized Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy

This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation.

Conditions
Breast Cancer
Being tested
Fulvestrant, GDC-0941, GDC-0941 Matching Placebo, GDC-0980, GDC-0980 Matching Placebo
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

    Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle, each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.

  • GDC-0941Drug

    Participants will receive GDC-0941 260 mg (Part II) or 340 mg (Part I) QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.

  • GDC-0941 Matching PlaceboDrug

    Participants will receive GDC-0941 matching placebo QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.

  • GDC-0980Drug

    Participants will receive GDC-0980 30 mg (Part I) QD orally from Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.

  • GDC-0980 Matching PlaceboDrug

    Participants will receive GDC-0980 matching placebo QD orally from Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.

Study groups in NCT01437566
Study groupRoleWhat they receive
GDC-0941 Matching Placebo + Fulvestrant (Arm E)Placebo comparatorParticipants with PIK3CA mutation will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0941 matching placebo QD orally starting on Day 1 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Receives: Drug: Fulvestrant; Drug: GDC-0941 Matching Placebo
GDC-0941-260 mg + Fulvestrant (Arm D)ExperimentalParticipants with PIK3CA mutation will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0941 260 mg QD orally starting on Day 1 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Receives: Drug: Fulvestrant; Drug: GDC-0941
GDC-0941-340 mg + Fulvestrant (Arm A)ExperimentalParticipants will receive fulvestrant 500 milligrams (mg) as 2 intramuscular (IM) injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0941 340 mg once daily (QD) orally starting on Day 15 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Receives: Drug: Fulvestrant; Drug: GDC-0941
GDC-0948 or GDC-0980 Matching Placebo + Fulvestrant (Arm C)Placebo comparatorParticipants will be randomized in 1:1 ratio to receive GDC-0948 matching placebo or GDC-0980 matching placebo with fulvestrant. Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0948 or GDC-0980 matching placebo QD orally starting on Day 15 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Receives: Drug: Fulvestrant; Drug: GDC-0941 Matching Placebo; Drug: GDC-0980 Matching Placebo
GDC-0980-30 mg + Fulvestrant (Arm B)ExperimentalParticipants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0980 30 mg QD orally starting on Day 15 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Receives: Drug: Fulvestrant; Drug: GDC-0980

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival as Assessed by the Investigator Per modified RECIST v 1.1

    Measured: From Screening to up to approximately 5 years (assessed at Screening, after 8, 16, 24 and 32 weeks of treatment, every 12 weeks thereafter until disease progression or initiation of other anti-cancer therapy)

  2. Percentage of Participants with Adverse Events

    Measured: Baseline to up to 30 days after the last dose of study drug (Approximately 5 years)

Secondary outcomes (7)

  1. Percentage of Participants with Objective Tumor Response (Complete Response [CR] or Partial Response [PR] as Assessed by the Investigator Per Modified RECIST v 1.1

    Measured: From Screening to up to approximately 5 years (assessed at Screening, after 8, 16, 24 and 32 weeks of treatment, every 12 weeks thereafter until disease progression or initiation of other anti-cancer therapy)

  2. Percentage of Participants with Clinical Benefit Response Defined as PR, CR, or SD Per Modified RECIST v 1.1

    Measured: From Screening to up to approximately 5 years (assessed at Screening, after 8, 16, 24 and 32 weeks of treatment, every 12 weeks thereafter until disease progression or initiation of other anti-cancer therapy)

  3. Duration of Confirmed Objective Response as Assessed by the investigator Per Modified RECIST v 1.1

    Measured: From Screening to up to approximately 5 years (assessed at Screening, after 8, 16, 24 and 32 weeks of treatment, every 12 weeks thereafter until disease progression or initiation of other anti-cancer therapy)

  4. Percentage of Participants with PIK3CA Mutant Tumors

    Measured: Baseline

  5. Time to Maximum Plasma Concentration (Tmax) of GDC-0941 and GDC-0948

    Measured: Part 1:0-4 hour (hr) predose (PrD), 1,2,4 hr postdose (PoD) on Day 15 of Cycles 1 & 2, PrD on Cycle 1 Day 16, 0-4 hr PrD & 2 hr PoD on Cycle 6 Day 1; Part II:0-4 hr PrD, 2 hr PoD on Day 1 of Cycles 1 & 6, 0-4 hr PrD, 1, 2, 4 hr PoD on Cycle 2 Day 1

  6. Maximum Plasma Concentration (Cmax) of GDC-0941 and GDC-0948

    Measured: Part 1:0-4 hr PrD, 1,2,4 hr PoD on Day 15 of Cycles 1 & 2, PrD on Cycle 1 Day 16, 0-4 hr PrD & 2 hr PoD on Cycle 6 Day 1; Part II:0-4 hr PrD, 2 hr PoD on Day 1 of Cycles 1 & 6, 0-4 hr PrD, 1, 2, 4 hr PoD on Cycle 2 Day 1

  7. Area Under the Concentration Time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of GDC-0941 and GDC-0948

    Measured: Part 1:0-4 hr PrD, 1,2,4 hr PoD on Day 15 of Cycles 1 & 2, PrD on Cycle 1 Day 16, 0-4 hr PrD & 2 hr PoD on Cycle 6 Day 1; Part II:0-4 hr PrD, 2 hr PoD on Day 1 of Cycles 1 & 6, 0-4 hr PrD, 1, 2, 4 hr PoD on Cycle 2 Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01437566
Sponsor's protocol ID
GDC4950g
Other IDs
GO00769, 2010-023763-17
Status last verified
Nov 2016
First submitted
8 Sep 2011
Last updated
2 Nov 2016
Results posted
No

Publications

  • Krop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, de Boer R, Petrakova K, Vallentin S, Perez EA, Piccart M, Ellis M, Winer E, Gendreau S, Derynck M, Lackner M, Levy G, Qiu J, He J, Schmid P. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Jun;17(6):811-821. doi: 10.1016/S1470-2045(16)00106-6. Epub 2016 May 4.

    PubMed 27155741

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fulvestrant, GDC-0941 and GDC-0980 in people with Breast Cancer, run by Genentech, Inc. at 130 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States, Germany, Israel, Italy, Australia and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival as Assessed by the Investigator Per modified RECIST v 1.1 (time frame: From Screening to up to approximately 5 years (assessed at Screening, after 8, 16, 24 and 32 weeks of treatment, every 12 weeks thereafter until disease progression or initiation of other anti-cancer therapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01437566, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in